MRI Procedure Manual for Examinations of the Knee and · PDF fileQualified radiology personnel at ... procedure manual is designed for the clinic coordinator, ... MRI Procedure Manual

MRI Procedure Manual for Examinations of the Knee and Thigh OAI Protocol

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SYN RC

MRI Procedure Manual for Examinations of the Knee and Thigh

Osteoarthritis Initiative: A Knee Health Study

W H E R E S C I E N C E M E E T S S E R V I C E


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OAI

PROTOCOL:

Osteoarthritis Initiative: A Knee Health Study

Version 1.0j October 3, 2006


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Clinic Coordinator and MRI Technologist’s Sign-Off

Dear Clinic Coordinator and MRI Technologist,

Synarc requires that the Clinic Coordinator and MRI Technologist read and fully understand the MRI Procedure Manual for the OAI study protocol. This requirement should be completed before imaging any participant in the OAI study. Additional requirements for OAI certification are listed in section 2.2 of the manual.

Please have all applicable study personnel sign and date this form to confirm completion of this requirement. Fax or mail a copy of this form to Synarc.

Alan Fong OAI Fax: 1-415-817-8999 Synarc, Inc. 575 Market Street, 13th Floor San Francisco, CA 94105

Principal Investigator:

Site Number:

Who is responsible for submitting packages to Synarc? O Clinic Coordinator O MRI Technologist

Clinic Coordinator

Printed Name Signature OAI Study ID # Date

MRI Technologist

Printed Name Signature OAI Study ID # Date

All new personnel for this study must comply with this requirement as well - - - Do not remove this page – send a photocopy only- - -


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MRI Technologist’s Follow-up Sign-Off Dear Clinic Coordinator and MRI Technologist,

The OAI requires that the MRI Technologist read and fully understand the MRI Procedure Manual for the OAI study protocol prior to the start of each new visit. This requirement should be completed before imaging any participant at the new follow-up visit. Please have all applicable study personnel sign and date this form to confirm completion of this requirement. When a technologist completes this requirement subsequent to the initial certification, i.e., prior to the start of a follow-up visit, this form should be mailed or faxed to Alisa Boyd:

Alisa Boyd SF Coordinating Center Fax: 1-415-514-8150 185 Berry Street Lobby 4, Suite 5700 San Francisco, CA 94107-1762

Principal Investigator:

Site Number:

MRI Technologist

Printed Name Signature OAI Study ID# Date

- - - DO NOT REMOVE THIS PAGE – SEND A PHOTOCOPY ONLY- - -


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TABLE OF CONTENTS

1.0 INTRODUCTION .............................................................................................................7

2.0 STUDY INTRODUCTION ..............................................................................................8

2.1 Protocol Overview .................................................................................................8

2.2 Summary of Responsibilities ................................................................................8

2.3 Inclusion & Exclusion Criteria ..........................................................................10 2.3.1 Major Inclusion Criteria .........................................................................10 2.3.2 Major Exclusion Criteria ........................................................................10

2.4 Patient Cohorts and Visits ...................................................................................11 2.4.1 Participant Cohorts and Schedule of MRI Examinations ..................11 2.4.2 Procedure for Repeat Exams .................................................................11

3.0 TECHNIQUE AND EXAMINATION PROCEDURES FOR MRI OF THE KNEE AND THIGH .................................................................................................................12

3.1 MRI Supplies and Forms ....................................................................................12

3.2 MRI Parameter Log .............................................................................................13

3.3 MRI Contraindications ........................................................................................13

3.4 Participant MRI Examination ............................................................................14 3.4.1 Labeling the Examination .......................................................................14 3.4.2 Positioning the Participant for the Knee MRI ......................................15 3.4.3 Imaging Sequences for the Knee MRI ...................................................16

3.4.3.1 Localizer (3-plane) ......................................................................17 3.4.3.2 COR IW TSE ..............................................................................17 3.4.3.3 SAG 3D DESS WE .....................................................................18 3.4.3.4 COR MPR SAG 3D DESS WE .................................................21 3.4.3.5 AXIAL MPR SAG 3D DESS WE .............................................22 3.4.3.6 SAG IW TSE FS .........................................................................23 3.4.3.7 COR T1 3D FLASH WE ............................................................24 3.4.3.8 SAG T2 MAP 120 mm FOV ......................................................26

3.4.4 Positioning the Participant for the Thigh MRI .....................................28 3.4.5 Imaging Sequences for Thigh MRI ........................................................30

3.4.5.1 Localizer ......................................................................................30 3.4.5.2 Axial T1-Weighted Images ........................................................30 3.4.5.3 Reference Image .........................................................................31

3.4.6 Labeling Images in the Electronic Header ............................................33 3.4.7 Daily Startup / Shutdown Procedures....................................................33 3.4.8 Criteria for Assessing Quality of MRIs .................................................34 3.4.9 On-site MR Image Quality Control .......................................................35

3.4.9.1 Sagittal 3D DESS WE ...............................................................35 3.4.9.2 Coronal 3D FL WE ...................................................................36 3.4.9.3 Coronal MPR of Sagittal 3D DESS WE ..................................36 3.4.9.4 Axial MPR of Sagittal 3D DESS WE .......................................37 3.4.9.5 Sagittal IW TSE FS ...................................................................37 3.4.9.6 Coronal IW TSE ........................................................................37 3.4.9.7 Sagittal T2 Map (MSME) .........................................................37


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3.4.9.8 Axial T1W (Thigh) ....................................................................38 3.4.10 OAI Participant CDs ............................................................................38

3.5 Technique and Examination Procedures for Quality Assurance of the Overall Siemens Trio System and Associated Coils .........................................39

3.5.1 Daily Quality Assurance Procedures .....................................................40 3.5.2 Weekly Quality Assurance Procedures ..................................................45 3.5.3 Monthly Quality Assurance Procedures ................................................46

3.5.3.1 Knee Coil – OAI Study Phantom ..............................................46 3.5.3.2 Body Coil S/N and Calc Artifacts Tests ....................................48 3.5.3.3 Head Coil – ACR Phantom ........................................................49 3.5.3.4 Siemens Preventative Maintenance ..........................................51

3.5.4 Annual Quality Assurance Procedures ..................................................51

4.0 DATA HANDLING PROCEDURES ...........................................................................54

4.1 Supplies .................................................................................................................54

4.2 Data Preparation ..................................................................................................54

4.3 Data Shipping .......................................................................................................54

APPENDIX I MRI Protocol Details ..............................................................................56

APPENDIX II MRI QA Protocol Details .......................................................................57

APPENDIX III Backup and Restore Protocols ..............................................................58

APPENDIX IV Quick Reference Guide ..........................................................................59

APPENDIX V Instructions for Completing the MRI Transmittal Form

and MRI Phantom Transmittal Form ................................................60

APPENDIX VI Instructions for Labeling the Electronic Media ..................................63

APPENDIX VII MRI Transmittal Form ...........................................................................64

APPENDIX VIII MRI Phantom Transmittal Form ........................................................65

APPENDIX IX OAI MRI Parameter Log ......................................................................66

APPENDIX X Daily QA Logsheet ..................................................................................68

APPENDIX XI Weekly QA Checklist .............................................................................69

APPENDIX XII Monthly QA Logsheet ............................................................................70

APPENDIX XIII MRI Supply Order Form .......................................................................71


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1.0 INTRODUCTION

The purpose of this manual is to standardize the MRI acquisition and assessment procedures among the centers participating in the OAI study.

Osteoarthritis Initiative: A Knee Health Study All radiologists and technologists contributing to this study are expected to have had appropriate theoretical and practical training in MRI. Study personnel should also satisfy all local requirements for radiology licensing and registration. Qualified radiology personnel at each clinical site are the first step toward the successful use of MRI in the OAI study. The procedure manual is designed for the clinic coordinator, the MRI technologists, and the radiologists involved in this study. The goal of this manual is to define a standard approach to acquire MRIs of the knee and thigh, applicable to the Siemens 3.0T Trio systems, which produces images of sufficient quality for achieving the study goals. It is not our position that the techniques proposed in this manual are the only ones to yield acceptable results. Rather, we are providing guidelines for uniform data collection with the goal of making the results of all participating study sites consistent and comparable. This is a key to the success of any multi-center study. This manual, taken alone, should not be considered as sufficient training in the proper technique for acquiring MRIs of the knee and thigh. The technologists involved in this study will get specific training from Synarc and will be certified based on central review of their MRIs. If there is a need to train additional technologists, please contact Synarc.

Questions regarding this manual or MRI technique should be directed to:

Alan Fong OAI Synarc Inc. 575 Market Street, 13th Floor San Francisco, CA 94105 USA

Telephone: 415-817-7918 Fax: 415-817-8999 Email: [email protected]

HOURS: 8.00 am – 5.00 pm (Pacific Time)


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2.0 STUDY INTRODUCTION

2.1 Protocol Overview The Osteoarthritis Initiative (OAI) cohort study is a multi-center, longitudinal, observational study of osteoarthritis (OA) focusing primarily on knee OA. The main focus of the OAI will be on knee OA because this is the site where OA symptoms most frequently cause significant loss of function and disability. The OAI’s primary objectives are to evaluate radiographic and MRI joint images as biomarkers for osteoarthritis and explore their potential as surrogate endpoints for clinical studies and treatment trials of knee OA. Because joint images are a central focus of OA, high quality knee MRI images acquired according to the standard protocols are critical to the success of the study. The OAI joint images will become part of a shared resource that will be available to researchers around the world.

Five thousand age-eligible women and men are being recruited and enrolled at five clinical centers in four U.S. cities. The study is comprised of two subgroups, 1) those with clinically significant tibiofemoral knee OA who are at risk of disease progression and 2) individuals who are at high risk of initiation of clinically significant knee OA. The baseline assessments consist of an initial eligibility assessment by telephone, a screening clinic visit and an enrollment clinic visit. There are four planned annual follow-up visits. Joint imaging biomarkers (magnetic resonance imaging and radiography) and biochemical and genetic markers (from blood and urine) are collected at baseline and at all follow-up visits. Participants are followed for changes in the clinical status of the knee and other joints, including worsening and onset of symptoms and disabilities, worsening and onset of knee structural abnormalities, and changes in other imaging and biochemical markers of OA.

2.2 Summary of Responsibilities

The role of the investigator site and MRI facility will be to:

• Complete the MRI technologist certification requirements: o Read and fully understand the OAI MRI Procedure Manual and submit the

completed Sign-Off form (page 3) to Synarc. o Receive training in the OAI MRI protocol by Synarc staff or another MRI

technologist certified for the study. o Pass central review of two certification exams on the imaging protocol, plus

one of each type of phantom exam. o Pass Synarc Quality Review for the first ten participant MRI examinations o Receive an OAI staff ID number from the study clinic coordinator.

• Perform MRI examinations of the knee and thigh and MRI scanner QA procedures according to procedures detailed in this manual

• Review MRI quality and obtain repeats as necessary before the participant leaves the MRI facility. Make comments on the transmittal form and the parameter log about any difficulties during the imaging process.


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• Send participant and phantom MRIs (in DICOM format, on CDs) and transmittal forms to Synarc as soon as possible after MRIs are acquired (preferably within 48 hours of the MRI exam)

• Maintain a permanent archive copy of all MRI examinations and transmittal forms submitted to Synarc for the duration of the study

The role of Synarc will be to:

• Certify the technologists who are taking MRIs for the OAI.

• Review the quality of MRIs by verifying that the parameters used are in agreement with the protocol and checking images for adequate anatomical coverage, signal-to-noise ratio, and the presence of artifacts. If necessary, provide suggestions for improvement to the MRI facility and request repeats as necessary.

• During the baseline visit, Synarc will review 100% of the participant knee images from each site. For future visits, Synarc will review 5% of the participant knee images from each site.

• Process and archive the submitted phantom scans.

• Email/Fax the quality review information to the Clinic Coordinator and primary MR contact within 5 working days of receiving exams.

• Email/Fax notification of the repeat request to the site within 3 working days of receipt.

• Note: SimplyPhysics will perform centralized quality assurance performance assessment for phantom scans and provide feedback on any potential problems with a rapid turnaround.

It is expected that the majority of examinations received will be of acceptable quality. If any problems are detected, however, Synarc will notify the responsible clinical site, suggest possible causes of the problem, and offer potential solutions to assist the site in producing a good quality repeat exam. The clinical site should try to avoid these errors in future exams. Acquisition of acceptable quality MRIs will remain the responsibility of the MRI facility.


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2.3 Inclusion & Exclusion Criteria

2.3.1 Major Inclusion Criteria

• Men and women ages 45-79. • All ethnic groups are eligible for the study, with an expected 23% of the cohort

from ethnic minority groups. • Participants must have knee pain or risk factors for knee OA. • Participants must have a complete set of acceptable quality knee images (MRI

and radiographs) at baseline.

2.3.2 Major Exclusion Criteria

• Rheumatoid Arthritis (RA) or inflammatory arthritis, defined as self-report of a physician diagnosis and ever use of any RA-specific prescription medications.

• Unlikely to demonstrate measurable loss of joint space during the study, defined

as severe joint space narrowing in both knees on the baseline knee radiograph.

• Bilateral total knee joint replacement or plans to have bilateral knee replacement. • Unable to undergo a 3.0 Tesla MRI exam of the knee because of

contraindications. • Positive pregnancy test.

• Unwilling to sign informed consent.


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2.4 Patient Cohorts and Visits

2.4.1 Participant Cohorts and Schedule of MRI Examinations

The OAI participants are split into three cohorts. The progression cohort (Pr) consists of participants with symptomatic knee OA at the beginning of the study. The incidence cohort (Inc) consists of participants who do not have symptomatic knee OA at the beginning of the study, but who have a high risk of developing knee OA. The normal control cohort consists of participants who do not have knee symptoms or radiographic evidence of tibiofemoral knee OA at the beginning of the study. In general, participants in all three subcohorts will have MRI examinations of the right and left knee at every visit, unless indicated otherwise on the Data from Prior Visits Report for that particular visit (see MRI Administrative Overview, Attachment A for examples of Data from Prior Visits Reports). The thigh MRI will be acquired at selected visits, as indicated on the Data from Prior Visits Report for the visit.

2.4.2 Procedure for Repeat Exams

Repeat exams should be performed as quickly as possible. Ideally, MRIs of insufficient quality should be identified by the MRI technologist at the time of acquisition and repeated immediately. Synarc will also centrally review MRIs for quality and require repeats when quality is inadequate. To facilitate this, Synarc will email the Clinic Coordinator and chief MRI technologist a repeat request query to indicate the need and reason for a repeat exam within 3 working days of receiving the MRIs. The site should then schedule the participant for the repeat exam. Repeat exams should be taken within 3 weeks of the original MRI. Synarc may ask for one repeat per participant at each visit. Synarc may request that only a subset of the exam be repeated. A new MRI Transmittal Form and a new MRI Tracking Form will need to be completed for the repeat visit.


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3.0 TECHNIQUE AND EXAMINATION PROCEDURES FOR MRI OF THE KNEE AND THIGH

In this section the specific requirements for the MRI examination are presented. Because of the need to assess small changes over time, the quality criteria for MRI in a study are stricter than in standard clinical practice. The most reliable evaluations of the MRIs require adherence to uniform acquisition and quality standards by all study sites involved. General Comments on MRI Technique

If you are unable to satisfy any of the required elements, please contact Synarc to discuss alternatives before you begin performing exams.

Contact: Alan Fong Tel. 415-817-7918 Fax 415-817-8999

Email: [email protected] Before each MRI examination, prepare the following:

• Have the MRI screening form available

• Have all positioning aids present in the procedure room

• Have the extremity coil in either L60 or R60 position

• Explain the examination procedure to the participant

• Have the Transmittal Form(s) ready to fill in

• Have study supplies ready to label digital media immediately

3.1 MRI Supplies and Forms

Listed below are MRI supplies and forms for use for MRI examinations:

• The OAI study phantom must be used for daily and monthly QA procedures.

• The ACR phantom must be used for monthly and annual QA procedures.

• Adhesive media labels (see Appendix VI) will be supplied by Synarc and must be used for all digital media.

• The MRI Transmittal Form (see Appendix VII) must be completed for each participant visit. Keep a photocopy of this form at the site and send the original along with the MRIs to Synarc.

• The MRI Parameter Log (see section 3.2 and Appendix IX) must be completed for each participant visit. Keep this form in the participant’s chart. Do NOT send this form to Synarc.

• At baseline the Final MRI Eligibility Assessment Workbook, and at follow-up, the MRI Safety Screener must be reviewed by the MR technologist, the participant, and a witness prior to the participant exam. The MRI Tracking Form must be completed for the MRI


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exam. This form should be scanned into the OAI data system and NOT sent to Synarc. Please be sure to file the original form in the participant’s chart.

3.2 MRI Parameter Log

The primary quality assurance goal for the subsequent MRIs is to reproduce the original MRI technique as closely as possible. Therefore, it is essential that an MRI Parameter Log be kept and used for each participant. Since parameters may vary slightly from participant to participant, consistent technique can be assured only if this log is referred to at each visit. Please see log in Appendix IX. The Parameter Log is also available on the OAI website under Documents and Forms / Study Forms / X-ray and MRI Parameter Logs. The Parameter Log must be kept in the participant’s chart. The clinic coordinator should pull the Log and send it with the participant each time they have MRIs done. The same Parameter Log should be used for all visits for a particular participant.

3.3 MRI Contraindications

Although participants will have been screened by the clinical center before reporting for their MRI exams, it is the responsibility of the technologist to review and confirm the absence of any MRI contraindications before each MRI exam, using the established criteria at each local site and the MRI Safety Screener (which will be provided to the technologist in advance of the participant’s exam). An OAI examiner or the MR receptionist needs to administer the Final MRI Eligibility Assessment (baseline) or MRI Safety Screener (follow-up) workbook to the participant before they are seen by the MRI technologist. The technologist reviews the questionnaire with the participant. The technologist, the participant, and a witness sign and date the form. The technologist can then proceed with the exam and complete the MRI Tracking Form. (The first three questions on the MRI Tracking Form should be completed before the participant gets to the technologist.)


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3.4 Participant MRI Examination

MRIs are done at every OAI visit. For details about which scans to acquire, see the Data from Prior Visits Report for that visit. For all MRIs, please concentrate on image quality and optimum positioning of the participant since follow-up MRIs will be compared to baseline MRIs to evaluate progression of the disease. The MRI technologist (or, in some cases, the MRI assistant/receptionist) needs to complete the following activities for each participant: • Receive and review consent forms prior to meeting participant. • Prepare MR patient table (ear plugs, sheets, head phone covers, squeeze ball, knee coils,

pads in place). • Meet and greet participant at reception area or door to facility and escort to scanner area. • Perform final MR safety screen and go over MR exclusions with participant prior to scan. • Show participant to changing room to change into appropriate dress for scan (if needed)

and to store belongings. • Escort participant to scanner. • Answer any remaining questions from participant. • Position participant and test communication system. • Run scans according to protocol. • Move participant out of scanner and escort back to dressing room. • Answer additional questions (if needed) and possibly print an image or burn a CD for

participant to take home. • Escort participant out of facility. • Perform post processing as needed on data sets, archive all images onto two CDs (one for

Synarc and one to be kept at the site). • Complete MRI Transmittal Form and MRI Tracking Form for each participant. • Clean up scanner room in preparation for next participant.

3.4.1 Labeling the Examination

Each participant is identified by a 7-digit OAI Participant ID and a 4-letter Acrostic (a code generated from their name), both assigned by the clinical center. The letter “L” or “R” is appended to the OAI Participant ID to indicate which knee is being imaged. Thigh studies will have an OAI Participant ID ending in "T". To preserve participant anonymity, only these identifiers should appear in the images. Names and other personal ID numbers (for example, Social Security numbers or Medical Record numbers) should NOT be used. The MRI exam order should be: Right Knee, Left Knee, Thigh. If the right knee is not eligible for MRI (generally because it has been replaced, which the MRI technologist will know from the MRI Screening Form), it will not be imaged. Instead, the left knee will be


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imaged using the LEFT KNEE FULL protocol (which includes coronal 3D-FLASH and sagittal T2-map sequences). If the left knee is ineligible, it is not imaged. In some cases, a metallic implant or foreign body not noted on the Screening Form will be observed in the localizer images of the right knee. If these produce significant artifacts that may obscure visualization of the articular cartilage, use the RIGHT KNEE SHORT protocol, Use the LEFT KNEE FULL protocol for the left knee, unless it too has an implant or foreign body. In that case, use the LEFT KNEE STD protocol. The knee imaging protocols are as follows:

Both knees are to be imaged: use RIGHT KNEE STD and LEFT KNEE STD protocols Right knee is ineligible: use LEFT KNEE FULL protocol Left knee is ineligible: use RIGHT KNEE STD protocol Both knees are to be imaged use RIGHT KNEE SHORT and LEFT KNEE FULL but right has metallic implant: protocols Both knees are to be imaged use RIGHT KNEE SHORT and LEFT KNEE STD and both have metallic implant:

The COR 3D-FLASH and SAG T2 mapping sequences are eliminated in the LEFT KNEE FULL and RIGHT KNEE SHORT protocols. The participants are registered in the scanner by entering the Acrostic in the Last Name field, and the OAI Participant ID (plus “L”, “R”, or “T”) in the Patient ID Field. The Acrostic is the first letter of the participant’s first name and the first three letters of their last name. For example, John Smith will be: Last Name JSMI Patient ID 4400012R Date of Birth, Sex, and Weight are entered appropriately, and Patient Position should be Feet-First Supine. OAI Right (Left) Knee should be selected from the Study drop-down list.

3.4.2 Positioning the Participant for the Knee MRI

Proper participant set up should ensure correct positioning of the knee and sufficient participant comfort to limit motion artifacts.

1. The knee coil base should be positioned on the table in alignment with the alignment

marks on the table. 2. The knee coil should be used in only the L60 or R60 positions. 3. The knee pad should be inserted into the coil; this is the only pad that should be used

beneath the knee such that the correct angle of flexion can be achieved in a consistent manner. The pad should be positioned such that it over hangs the coil edge by -1.5cm.

4. The knee should be positioned in the coil such that the bottom of the patella is aligned with the center mark of the coil.


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5. The leg should be in a relaxed, neutral position. 6. The foot should be vertical, with medial foot and the big toe orthogonal to the bed.

The foot should be sandbagged to retain this position. 7. The air cushion should be positioned centered on the patella (remove air first, leave

valve open) before securing the top and bottom halves of the RF coil. 8. A positioning strap should be used secure both the coil and the contralateral knee.

Pads should be used to ensure patient comfort. 9. The landmark position should be the center of the RF coil (align with marks) which

should correspond to the bottom of the patella.

3.4.3 Imaging Sequences for the Knee MRI

OAI MRI protocols, including all sequences for both right and left knee exams as well as the thigh exam, will be provided on CD. The protocols and specific parameters are included in Appendix I. These should be loaded from the source CD into the scanner sequence library in order to speed up the examination and limit the potential of human error (see Appendix III for specific instructions on loading protocols). At the beginning of an exam, the entire Right (Left) Knee (Thigh) protocol can then be copied from the sequence library into the active window of the scanner console. Only minor changes in TR, when prompted by the scanner due to SAR limits, and phase oversampling should then be necessary; other parameters should not be changed. However, it is easy to inadvertently change sequence parameters, especially when copying slice and sat band positions using the “Copy Parameter” command. Due caution should be exercised to avoid mistakes. Right Knee Std Exam (Extremity RF coil positioned at R60): The Right Knee Std Exam consists of the following acquisitions (with scan duration in minutes). Scan slice / slab center locations and oblique angulation should be identical for similar acquisition planes (i.e., all sagittal acquisitions should be prescribed the same; likewise all coronal scans should be prescribed the same). The scan acquisition order should not be changed; otherwise, long term SAR will be increased. Please note that the scan times detailed below are estimates, and actual times may vary somewhat.

Notes: The reconstructions (MPRs) can be done at any point after acquisition of the

DESS sequence, even during other sequence acquisitions.

Duration in Minutes No. Scan R knee L knee Total 1 Localizer (3-plane) 0.5 0.5 1.0 2 COR IW TSE 3.4 3.4 6.8 3 SAG 3D DESS WE* 10.6 10.6 21.2 4 COR MPR SAG 3D DESS WE 0.0 0.0 0.0 5 AXIAL MPR SAG 3D DESS WE 0.0 0.0 0.0 6 SAG IW TSE FS 4.7 4.7 9.4 7 COR T1W 3D FLASH WE 8.6 - 8.6 8 SAG T2 MAP 120 mm FOV 10.6 - 10.6 Total 38.4 19.2 57.6


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COR T1W 3D FLASH WE and SAG T2 MAP are done in the right knee only, unless the right knee is a knee replacement or there are metallic implants or foreign bodies seen on the right knee localizer, in which case these two sequences are performed on the left knee (see knee imaging protocols on page 15).

Left Knee Std Exam (Extremity RF coil positioned at L60): The Left Std Knee Exam is identical to that for the Right Knee, except that the Cor 3D T1 FLASH WE and Sag T2 Map sequences are omitted. Again, scan slice / slab center locations and oblique angulations should be identical for similar acquisition planes (i.e., all sagittals are prescribed the same; all coronal acquisitions are prescribed the same). Likewise the scan acquisition order should not be changed; otherwise long term SAR will be increased. IMPORTANT: Participants with metallic implants in an eligible right knee should have the FULL knee protocol (including the COR T1W 3D FLASH WE and SAG T2 MAP sequences) done on their left knee and the SHORT protocol done on their right knee. The prescription of slice and sat band locations are described in the following pages.

3.4.3.1 Localizer (3-plane) This is a conventional three-plane localizer. Offsets for R60 and L60 coil positions are pre-programmed into the corresponding exam sequences.

3.4.3.2 COR IW TSE The Coronal IW exam is intended for evaluation of joint alignment, cartilage morphology, osteophytes, the body of the menisci, collateral ligaments and for the presence / extent of subchondral bone cysts and attrition. This Coronal scan is a double oblique acquisition. The slices are prescribed from the axial localizer with the largest femoral condyles and from the mid-joint sagittal and coronal localizers. The slices are first oriented such that they align (are parallel to) the posterior femoral condyle surface on the axial localizer. Next, using the sagittal localizer, move the center of the imaging FOV to the tip of the femur in the joint. Then, move (rotate) the top (superior) center of the imaging FOV to the center of the femoral shaft (diaphysis). Now, the alignment is correct and results in a line tangential to the posterior femoral condylar surfaces in the axial plane, and parallel to the femoral-tibial axis in the sagittal plane. Finally, move (translate only!!) the imaging FOV (without changing either alignment axes) such that joint is centered. Check all three localizer planes to ensure that the joint is fully covered and only subcutaneous fat regions will overlap.


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Scan prescription for Coronal IW TSE

With large knees, slice coverage and phase aliasing artifact issues may occur with this 140mm FOV acquisition. Adjust the imaging locations such that only regions of subcutaneous fat overlap.

3.4.3.3 SAG 3D DESS WE The Sagittal 3D DESS with Water Excitation is a single oblique acquisition, oriented such that the sagittal slices are perpendicular to a line tangential to the posterior surfaces of the femoral condyles. This acquisition will provide information for total joint cartilage thickness and volume. In addition, information about osteophytes, subarticular bone cysts and bone attrition, and possibly collateral ligaments will be available. First, find the axial localizer slice with the largest cross-section through the condyles and the mid-joint sagittal and coronal localizer. The correct oblique angle is identified by moving (rotating and translating) the 3D imaging FOV (box) such that its posterior limit just touches both of the posterior condylar surfaces. Then, without changing the angulation, center the box over the knee. Now check the imaging FOV such that it is centered in the coronal and sagittal planes, and adjust if necessary. Do not change the number of slices in the protocol, even for small knees.


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Scan Prescription for Sagittal 3D DESS with Water Excitation

Scan Example of Sagittal 3D DESS with Water Excitation

Care must be taken with slice prescription of any of the Sagittal 3D acquisitions because the 14cm FOV may result in aliasing in large knees. Aliasing artifacts are acceptable as long as patellar, femoral, and tibial cartilage are not obscured. Two examples of unacceptable aliasing artifacts from the sagittal 3D acquisitions are located below.

Example of gross slice under coverage (sagittal acquisition with axial and coronal MPR). Red stars and arrows identify aliasing.


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Example of a more subtle artifact which impinges only on the cartilage of one condyle (equally unacceptable). This artifact should be eliminated by positioning the imaging FOV such that the wrap only occurs in the subcutaneous fat.


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3.4.3.4 COR MPR SAG 3D DESS WE The Coronal multi-planar reformatting of the Sagittal 3D DESS with Water Excitation does not require further acquisition. Please perform 1.5mm Coronal MPR reformats (approximately 64 slices) of the Sagittal 3D DESS with Water Excitation. The coronal reconstructions should be obliqued to correspond to the slices in the primary coronal acquisitions.


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3.4.3.5 AXIAL MPR SAG 3D DESS WE The Axial multi-planar reformatting of the Sagittal 3D DESS with Water Excitation does not require further acquisition. Please perform 1.5mm Axial MPR reformats (approximately 64 slices) of the Sagittal 3D DESS with Water Excitation.


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3.4.3.6 SAG IW TSE FS The Sagittal IW with Fat Suppression exam is for evaluation of the effusion volume, the anterior and posterior femoral and tibial osteophytes and for the presence / extent of subchondral bone cysts and attrition. This Sagittal scan is a single oblique acquisition, oriented such that the sagittal slices are perpendicular to a line tangential to the posterior surfaces of the femoral condyles. The easiest manner to create this scan prescription is to copy the center of the slice locations from the 3D DESS image, move the imaging FOV slightly superior such that the bottom of the imaging FOV is just below the tibial ephiphysis, and then move both the superior and inferior saturation bands outside the imaging FOV. However, if this exam needs to be repeated, the instructions follow. First, find the axial localizer slice with the largest cross-section through the condyles and the mid-joint sagittal and coronal localizer. The correct oblique angle is identified by first rotating and translating the imaging FOV such it is aligned with and touches both of the posterior condylar surfaces (appears to be an oblique coronal acquisition). Then, without changing the angulation, perform a right mouse click and select make slices orthogonal (now appears to be sagittal oblique acquisition). Finally, center the imaging FOV (translate only!!) over the knee in the axial plane. Now check the imaging FOV such that it is centered in the coronal and sagittal planes, and adjust if necessary. Finally, using the sagittal localizer, move the imaging FOV superiorly such that the bottom (inferior) part of the imaging FOV is slightly below the tibial epiphysis. It is likely that the superior and inferior saturation bands will need to be moved such that they are outside the imaging FOV as shown in the example below. With very large knees, phase aliasing artifact may occur with this 160mm FOV acquisition. Adjust the imaging locations such that only regions of subcutaneous fat overlap.

Scan prescription for Sagittal IW TSE

Allowed phase wrap for this acquisition would occur only in the subcutaneous fat regions as for all the other sagittal examinations.


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3.4.3.7 COR T1 3D FLASH WE The Coronal 3D FLASH with Water Excitation is a sequence commonly used for cartilage thickness measurements and volume segmentation. This 160mm FOV acquisition should fully cover the femoral chondyles and tibial plateau. This Coronal scan is a double oblique acquisition. The easiest manner to create this scan prescription is to copy the center of the slice locations from the 3D DESS image and adjust (translate only) the imaging FOV to minimize any phase wrap. Check in both the Sagittal and Coronal localizer planes If this exam needs to be repeated, the scan prescription instructions follow. The imaging volume is prescribed from the axial localizer with the largest femoral condyles and from the mid-joint sagittal and coronal localizers. The imaging volume (box) is first oriented such that the posterior edge aligns with (touches) the posterior femoral condyle surface on the axial localizer. This is shown below.

Next, use the sagittal localized and move the center of the imaging FOV to at the tip of the femur in the joint. And now move the top (superior) center of the imaging FOV to the center of the femoral shaft (diaphysis). Now, the alignment is correct and results in a line tangential to the posterior femoral condylar surfaces in the axial plane, and parallel to the femoral-tibial axis in the sagittal plane. Finally, move (translate only!!) the imaging FOV (without changing either alignment axes) such that joint is centered. Check all three localizer planes to ensure that the joint is fully covered and only subcutaneous fat regions will overlap.


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Position FOV so that complete coverage of the joint is obtained and any aliasing does not obscure structures of interest.

Scan Example of Coronal T1 3D FLASH with WE

Do not change the number of slices in the protocol, even for small knees. With large knees, a limited possibility for phase aliasing artifact exists with this 160mm FOV acquisition. It should be possible in all instances to place the imaging FOV in a manner such that the only wrap occurs on subcutaneous fat tissue. An example of allowed phase wrap is below.

Allowed phase wrap for this acquisition should occur only in the subcutaneous fat regions as shown by the arrows.


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3.4.3.8 SAG T2 MAP 120 mm FOV The Sagittal T2 mapping sequence is a small FOV exam intended to cover both the patellar and femoral / tibial cartilage only. Using this acquisition, the cartilage morphology and condition, the anterior and posterior meniscal horns, the cruciate ligaments, anterior / posterior femoral and tibial osteophytes, superior / inferior patellar osteophytes, as well as subchondral bone cysts and attrition may be assessed. This Sagittal scan is a single oblique acquisition, oriented such that the sagittal slices are perpendicular to a line tangential to the posterior surfaces of the femoral condyles. The easiest manner to create this scan prescription is to copy the center of the slice locations from the 3D DESS image and move (translate) the imaging FOV to minimize the impact of any phase wrap. Check in both the Sagittal and Coronal localizer planes! If this exam needs to be repeated, the scan prescription instructions follow. First, find the axial localizer slice with the largest cross-section through the condyles and the mid-joint sagittal and coronal localizer. The correct oblique angle is identified by first rotating and translating the imaging FOV such it is aligned with and touches both of the posterior condylar surfaces (appears to be an oblique coronal acquisition). Then, without changing the angulation, perform a right mouse click and select make slices orthogonal (now appears to be sagittal oblique acquisition). Finally, center the imaging FOV (translate only!!) over the knee in the axial plane. Now check the imaging FOV such that it is centered in the coronal and sagittal planes, and adjust if necessary. With large knees, phase aliasing artifact will probably occur with this 120mm FOV acquisition. Adjust the imaging locations such that only regions of subcutaneous fat overlap.

Scan prescription for Sagittal T2 map


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Acquisition on a small knee Allowed phase wrap for this acquisition

would occur only in the subcutaneous fat regions as shown by the red arrows


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3.4.4 Positioning the Participant for the Thigh MRI

1. Assess eligibility for thigh examination. Participants with knee or thigh prostheses are not eligible. If participant is ineligible, indicate appropriately on form. Participants will not be re-scheduled specifically for the thigh examination.

2. Following the knee MRI, the knee coil should be removed for the thigh acquisitions and the table cushion replaced. Have the participant remain on the table, sit up and turn legs to the side so that pads and cushions can be put into place.

3. Place positioning sponge (see #1 in photo on next page) at the foot end of the table. 4. Ask the participant to lie supine on the table in a feet-first orientation. The legs

should be relaxed and straight in the center of the MR patient table, but not inverted or everted. The participant’s feet should be at the very end of the table and should be supported by the foam wedge. If the participant cannot lie in this position, note whether there is inversion or eversion of the feet and whether the shift from midline is MILD (10-30 DEGREES), MODERATE (30-45 DEGREES) or EXTREME (MORE THAN 45 DEGREES) on the OAI MRI Transmittal Form.

5. The hips should be aligned with the long axis of the patient table. If the participant cannot lie flat on the table, note this on the protocol completion form in the comments.

6. The large foam wedge spacer (see #2 in photo on next page) should be placed between the knees at the level of the patella with about 3” of the narrow (tapered) side located above the knee joint and facing upward. Note: On some larger participants, it may be necessary to remove this wedge spacer between the knees so that their legs will not be spread too far apart.

7. Place one thin (1 cm) blue foam pad (see #3 in photo on next page) between the ankles.

8. Place long sandbags along the length of outside of each of the lower legs to keep legs from everting (rolling outward), or if eversion is the only position they can maintain, from everting further.

9. The feet should be nearly vertical but relaxed. The feet should be lightly taped to hold them in place, and the legs sandbagged to retain this position.

10. Two positioning straps should be used just above and just below the knees to maintain the position.

11. Landmarking: Palpate the apex of the patella. The landmark position should be 15cm above the patellar apex. If the patellar apex cannot be palpated, estimate where this apex should be. A plastic ruler cut off at precisely 15 cm has been supplied to facilitate this landmarking so that the mid thigh region will be in the center of the field of view. Note: If participant is not able to proceed far enough into scanner bore to landmark at 15 cm, re-landmark at a position that allows them to go as far into the scanner bore as possible.

12. Place earplugs and headphones back on participant. Indicate to participant that this last scan should take less than 10 minutes.


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Placement of pads for thigh MRI acquisition.

Positioning of participant for thigh MRI acquisition.

#1 #2#3


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3.4.5 Imaging Sequences for Thigh MRI

3.4.5.1 Localizer

1. The bi-planar (Coronal and Axial) localizer should cover the femoral-tibial joint and proximally.

2. The Localizer needs to be bi-planar (coronal and axial, with sufficient spatial resolution along the S/I axis on the coronals to identify the right medial femoral epiphysis).

3.4.5.2 Axial T1-Weighted Images 1. Choose the coronal localizer that best visualizes the right femoral epiphysis. Position

the axial T1W scans such that the bottom slice is at the medial femoral epiphysis of the RIGHT knee (red arrow represents the bottom slice; the top arrow represents the approximate top slice location). For the scan of the thigh, a set of 15 contiguous axial images will be obtained. 7 cm will be covered,

2. Offset the bottom of slices (if 5mm/skip 0mm slices are selected) by 10cm (100 mm) toward the head (This will mean subtracting 100 from the F mid-slice location).

3. Perform manual 3D Shimming. Iterate 3 times please. 4. Please ensure that the imaging FOV covers the entire thigh circumferential region on

the axial localizers. 5. Using the axial localizers, check the R/L and A/P positioning the of the axial T1W

acquisitions to obtain as many slices as possible which contain all the subcutaneous fat from both the right and left leg.

6. If FDA SAR limits are encountered, increase the number of concatenations to three (3). DO NOT change TR or TE.

Approx. Top Slice Location

Landmark position

Approx. Bottom Slice Location


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Example of Thigh Axial T1-Weighted Image.

3.4.5.3 Reference Image

Please create, store, backup and transmit to Synarc a reference image (coronal localizer on which the center location of the T1W axial slices are displayed). To capture the reference image (coronal image from which the axial images were prescribed): 1. Complete the T1W axial acquisition; 2. Display the T1W axial series in a viewing window on the Trio system (not the

Leonardo workstation!); 3. Select the position display series button on the task card (right side, choose the option

with the small head with lines across it – see yellow arrow).


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The cross reference image will automatically display and it will be automatically saved to the Trio data base with a 5001 number. It may be necessary to manually send this reference image to the Leonardo workstation. See figure below for an example.


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3.4.6 Labeling Images in the Electronic Header

Left and Right knee exams for a given participant each should be registered as separate studies with the OAI Participant ID ending in “L” or “R”, respectively. The Thigh exam should also be registered separately with the OAI Participant ID ending in “T”. The following information should be entered to register the participant for an MRI exam:

In the “Last Name” field, enter the 4-letter Acrostic Here is an example of how the Last Name field should appear:

Last Name: JSMI

In the “Patient ID” field, enter: OAI Participant ID # R (L) (T)

Here is an example of how the Patient ID field should appear:

Patient ID: 4400012R

In the “Additional Info” field, enter the Visit Code:

Here is an example of how the Additional Info field should appear:

Additional Info: BL

Below is a list of possible entries for the Visit Code:

BL = Baseline (Enrollment Visit) 12 = 12 month follow-up 18 = 18 month follow-up 24 = 24 month follow-up 30 = 30 month follow-up 36 = 36 month follow-up 48 = 48 month follow-up R = Repeat (any visit)

3.4.7 Daily Startup / Shutdown Procedures

At the beginning of each working day, the system should be restarted (blue button in wall-mounted switch box). This will re-boot the console computer. Run the Siemens Customer QA procedure for the Extremity Coil. Then run the OAI Daily QA scan at either R60 or L60 and measure and record the results (see section 3.5.1). Other beginning of day activities could include running the Head Coil S/N DIP under the Customer QA menu.

At the end of each working day, put the MR patient table in the fully out position and place the Siemens extremity coil phantom in the extremity RF coil at isocenter. Then, the system should be shut down. Select "System, End", wait for shutdown, then turn off power using the


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blue button in wall-mounted switch box. Other end of day activities include preparing the forms and CDs for shipment to Synarc and arranging for FedEx pickups.

3.4.8 Criteria for Assessing Quality of MRIs

The quality of the MRIs must be sufficient to allow for an accurate determination of morphological features of the knee. The following image characteristics will be evaluated by Synarc as part of the quality assessment:

Good Anatomical Coverage Proper FOV placement and adequate number of slices for each sequence as specified in Section 3.4.3.

Aliasing Aliasing can be tolerated as long as structures of interest are not obscured (see Section 3.4.3).

Participant Motion Usually can be avoided by use of pads and sandbags, and by instructions to participant.

Pulsatile Motion Artifacts from the popliteal artery are often unavoidable, but can be minimized by proper placement of sat bands (see Section 3.4.3).

Chemical Shift Minimized by proper choice of band-width and frequency encode direction. The optimal phase encode direction and receiver bandwidth has been pre-programmed into each sequence, and should not be changed.

Fat Saturation Failure Partial fat sat failure is tolerable at the image periphery as long as the contrast of structures of interest (for example, cartilage or bone marrow edema) is not compromised.

Susceptibility Effects May arise from implants and other metallic objects; acceptable if they do not obscure structures of interest

Occasionally, problems such as patient motion, susceptibility artifacts, etc, cannot be avoided. Those should be noted in the Comments section of the Transmittal form, particularly if they are likely to recur in any repeat examination.


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3.4.9 On-site MR Image Quality Control

The MR Technologists are the primary gatekeepers to ensure only good quality MR exams are incorporated into the OAI image database. Not only must the technologists acquire each MR exam as described in the protocol, they must also inspect each image series, immediately re-acquiring those which do not meet the specifications detailed below, and send only the best image series to Synarc for archive. Synarc performs QA on about 10% of the MR exams acquired for the OAI. If it is necessary to acquire multiples of the same image series, please only send the best series to Synarc. If even the second (or third) series will not pass QA, please include the one best image series and note on the Transmittal Form that this was the best achievable on this particular participant. If none of the multiple series is clearly the best, please send all of the images series to Synarc with a request on the Transmittal Form to please QA this exam. Synarc will then select the most appropriate image series for inclusion into the OAI image database. For any participant to be enrolled in the study, the following MR acquisitions must pass quality checks:

• Sagittal 3D DESS WE (both Right and Left knees) • Coronal and Axial MPR of 3D DESS WE (both Right and Left Knees) • Coronal 3D FL WE (Right knee only, except as previously described)

In addition, for progression cohort participants to be enrolled in the study, the following additional MR acquisitions must pass quality checks:

• Sagittal MSME (T2 Map) • Coronal IW TSE • Sagittal IW TSE FS

Sequence specific criteria follow:

3.4.9.1 Sagittal 3D DESS WE • Cartilage must be measurable over the entire tibial plateau, femoral condyles,

trochlea and patella. Scan must be repeated for any reason this is not accomplished, including incomplete anatomical coverage, aliasing, severe motion, etc.

• Anatomic coverage must extend slightly beyond the bones of interest (tibia, femur, patella) and cartilage, but does not need to span the complete soft tissue nor does it need to span the full fibular head. Complete coverage of the patella is desirable, but not required.

• Coverage should be checked using the 3D reformat page (MPR) to ensure that soft tissue aliasing does not wrap onto the bones of interest or cartilage. See section 3.4.3.3 SAG 3D DESS WE for specific examples.


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3.4.9.2 Coronal 3D FL WE • Cartilage must be measurable over the entire tibial plateau and femoral condyles.

Scan must be repeated for any reason this is not accomplished, including incorrect slice orientation (see next bullet), incomplete anatomical coverage, aliasing, severe motion, etc.

• Posterior femoral condyles must appear within a maximum of 3 consecutive slices (double bulls eye as shown on left starts slice 1). Ideally the medial and lateral femoral condyles appear in the same slice as shown in this example.

• Anatomic coverage must extend slightly beyond the bones of interest (tibial plateau

and complete femur) and cartilage, but does not need to span the complete soft tissue nor does it need to span the full fibular head. Coverage of the complete patella is not required.

3.4.9.3 Coronal MPR of Sagittal 3D DESS WE • Identical criteria to Coronal 3D FL WE.

• Cartilage must be measurable over the entire tibial plateau and femoral condyles. MPR must be repeated for any reason this is not accomplished, including incorrect scan slice orientation (see next bullet), incomplete anatomical coverage, etc.

• Posterior femoral condyles must appear within a maximum of 3 consecutive slices (double bulls eye as shown on left starts slice 1). Ideally the medial and lateral femoral condyles appear in the same slice as shown in this example.

• Anatomic coverage must extend slightly beyond the bones of interest (tibial plateau and complete femur) and cartilage, but does not need to span the complete soft tissue nor does it need to span the full fibular head. Coverage of the complete patella is not required.


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3.4.9.4 Axial MPR of Sagittal 3D DESS WE • Cartilage must be measurable over the entire patella and femoral trochlea. MPR must

be repeated for any reason this is not accomplished, including incomplete anatomical coverage, etc.

• Anatomic coverage must include all osteophytes and extend above the patella as well as below the tibial plateau. It is not necessary to span the complete soft tissue nor does the MPR need to span the full fibular head. Coverage of the complete patella and all osteophytes is required.

3.4.9.5 Sagittal IW TSE FS • The complete joint and joint capsule must be contained in this exam because it is

intended for evaluation of the effusion volume, the anterior and posterior femoral and tibial osteophytes and for the presence / extent of subchondral bone cysts and attrition.

• Anatomic coverage must include all osteophytes and extend posteriorly to include the popliteal artery and anteriorly to completely cover the patella. Superiorly it is necessary to cover as much of the supra-patellar pouch as possible and to cover below the tibial plateau inferiorly. It is not necessary to span the complete soft tissue medially / laterally. However, the lateral extent should span the full fibular head. Coverage of the complete patella and all osteophytes is required.

3.4.9.6 Coronal IW TSE • The complete joint must be contained in this exam because it is intended for

evaluation of joint alignment, cartilage morphology, osteophytes, the body of the menisci, collateral ligaments and for the presence / extent of subchondral bone cysts and attrition.

• Anatomic coverage must include all osteophytes and extend posterior to the femoral condyles as well as anterior to the patella. It is necessary to include the collateral ligaments medially / laterally as well as the complete fibular head. Coverage of the complete patella and all osteophytes is also required.

3.4.9.7 Sagittal T2 Map (MSME) • This exam is focused on evaluation of the patellar and femoral / tibial cartilage only.

Using this acquisition, the cartilage morphology and condition, the anterior and posterior meniscal horns, the cruciate ligaments, anterior / posterior femoral and tibial osteophytes, superior / inferior patellar osteophytes, as well as subchondral bone cysts and attrition may also be assessed, however their coverage is not paramount.

• Anatomic coverage of the T2 map must be bone to bone (medial – lateral) and must not include aliasing in the patellar cartilage. It should include all osteophytes. But does not need cover the patella.


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3.4.9.8 Axial T1W (Thigh) • The imaging FOV should cover the entire thigh circumferential region, including all

subcutaneous fat. Subcutaneous fat outside the FOV is acceptable if participant is grossly obese. ALL muscle in both thighs must be within the FOV.

• Check images for artifacts including patient motion, etc.

• Double check that a coronal localizer image (reference image) is included.

3.4.10 OAI Participant CDs

When providing OAI participants selected MR images upon request:

• A copy of the letter (OAI Memo #1081) in DICOM format should be burned onto each CD, along with a copy of the DICOM viewing software.

• A printed copy of the letter (OAI Memo #1081) should be handed to each OAI participant who receives any electronic MR images.

Per the OAI Imaging Working Group, the Right knee and Left knee Sagittal IW TSE FS images should provide the most clinically useful information. Only these images should be included on the CD, unless the participant specifically asks for all their images. Under no circumstances should it be stated or implied that the OAI MR exam is the same as a clinical MRI exam used to diagnose medical conditions.


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3.5 Technique and Examination Procedures for Quality Assurance of the Overall Siemens Trio System and Associated Coils

The Osteoarthritis Initiative will provide a large set of knee MR images that will be available to the public. It is likely that different image processing techniques will be used on these images in the future. Each of these techniques will have specific optimal image characteristics, such as contrast-to-noise, signal-to-noise, specific tissue contrast, and slice thickness. It is impossible to optimize a priori the acquisition of OAI images to all techniques. What is required in the OAI, therefore, is to provide uniform high quality longitudinal images with minimal artifacts. The Quality Assurance procedures in the Osteoarthritis Initiative have been designed with these specific aims in mind:

1. Provide uniformly high quality artifact-free images from all sites 2. Provide longitudinal consistency across all sites of key image characteristics such as

signal-to-noise, contrast-to-noise, signal homogeneity, local and global distortion 3. Provide a means to compare MR data acquired from each of the four 3T systems 4. Minimize need to repeat imaging by correcting slowly developing problems before

image quality is affected Summary of QA procedures: All coils and cables must be visually inspected for loose components, breaks, and cracks weekly. Siemens field service engineers will perform preventative maintenance at all sites on a monthly basis. Site technologists and Synarc technologists and/or radiologists will evaluate OAI participant images on a regular basis (all images at baseline; 5% of images for follow-up visits) and will also compare the quality between sites.

There are DAILY, WEEKLY, MONTHLY, and ANNUAL QA procedures:

DAILY: Extremity Coil S/N check; OAI Study Phantom geometry and S/N check

WEEKLY: Head Coil S/N check Backup extremity coil S/N check Physical inspection of all coils, phantoms, magnet bore, screen room door

MONTHLY: 1. Daily QA, T2 measurement, and 3D volume acquisition with the OAI study phantom.

2. Siemens Body Coil S/N and Calc Artifacts QA 3. Modified ACR Phantom Test Protocol 4. Siemens Preventative Maintenance by Field Service Engineer (Note: Each of these four tests should be scheduled for different weeks of

the month.) ANNUAL: ACR Acceptance Testing (standard and modified protocol)


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3.5.1 Daily Quality Assurance Procedures

The following quality assurance protocol should be followed DAILY:

• The OAI specific QA phantom is cylindrical (inside diameter 114mm, inside length 114 mm) and contains a hollow sphere of 57 mm inside diameter; each compartment contains a different MRI-visible Gd solution.

• The knee coil should be positioned at the R60 (Monday, Wednesday, Friday) or L60 (Tuesday, Thursday, Saturday) location.

• Register the exam as follows:

SITE EXAM NAME DAILY QA* MONTHLY QA: KNEE COIL

HEAD COIL: ACR

PHANTOM

ANNUAL ACR TEST

Phantom ID: 46POAIA 46POAIA 46PACRA 46PACRA OHIO

Acrostic: ODQL or ODQR OMQL or OMQR OMMM OAAA Phantom ID: 58POAIA 58POAIA 58PACRA 58PACRA

PITTSBURGH Acrostic: PDQL or PDQR PMQL or PMQR PMMM PAAA Phantom ID: 34POAIA 34POAIA 34PACRA 34PACRA

MARYLAND Acrostic: MDQL or MDQR MMQL or MMQR MMMM MAAA Phantom ID: 10POAIA 10POAIA 10PACRA 10PACRA

RHODE ISLAND Acrostic: RDQL or RDQR RMQL or RMQR RMMM PAAA

• If it becomes necessary to change the study phantom during the study, please use

“OAIB” as the last four characters in the Patient ID. Continue to increase the number by one for each phantom that is used.

Phantom Set-Up:

• Set up the study phantom in the center of the knee coil with two thin (1cm) green cushions on the bottom (remove the grey patient knee pad) and two thick (2cm) green cushions on top. The phantom should be positioned such that the fill ports are vertical (see photo below).


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• Carefully align the phantom and coil using the laser beam to ensure that both coil and phantom are orthogonal to magnet bore.

• Let the phantom settle for 2-3 minutes.

Daily QA Scan Acquisition and Analysis:

• Run the OAI Daily Phantom protocol:

• 3-plane localizer

• Sagittal 2D IW TSE. The first slice should be at one edge of the inner sphere; the last slice should be at the other edge of the inner sphere as shown below. This will allow more reproducible positioning of the center slice to be at the center of the inner sphere.

Prescription Hints: Ignore the screw positions. Center outer slices such that equal amounts of fluid (white) are on either side of the slices.

Scan prescription for Sagittal 2D IW TSE

• Axial 2D IW TSE. The first slice should be at one edge of the inner sphere; the last slice should be at the other edge of the inner sphere as shown below. This will allow more reproducible positioning of the center slice to be at the center of the inner sphere.

Prescription Hints: Ignore the screw positions. Center outer slices such that equal amounts of fluid (white) are on either side of the slices.

Scan prescription for Axial 2D IW TSE


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• For analysis, select the center axial and sagittal slices as shown below. Vary the window/level settings from minimum to maximum and look for intensity inhomogeneities. Although the signal intensity will vary across the FOV, the variations should be approximately symmetrical. Failure of coil elements or gradients will often first appear as inhomogeneities or distortions in the FOV. Increases in the signal intensity of "ghost" images along the phase encode direction are another indicator that system will require an extensive service and tune-up. Visual comparisons to reference images from the preceding day or week will be helpful.

• Using a circular ROI that largely covers the inner portion of the sphere (around 14

cm2), measure and record (on the Daily QA log sheet) the signal intensity mean and standard deviation in the center of the sphere in the center axial slice. Measure noise signal intensity in an elliptical ROI of about 0.5-1.0 cm2 outside of the phantom in both frequency and phase directions (left or right, top or bottom). Record values in the Daily QA Log Sheet. Day to day variations should be less than the following limits:

Signal Intensity 5 % Signal Std Dev 10 % Noise 10 % Ghosting 10 %


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• Using the ruler tool on both axial and sagittal images, measure the maximum horizontal and vertical inside dimensions of the cylinder. The apparent diameter will vary depending upon the window/level settings. Set Window at zero and level to the mean signal intensity measured above. Observed diameters and lengths should be 114 mm ± 1 mm. Record on Daily QA logsheet.


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• Send the exam to Synarc on a CD. It can be included with participant exams on the

same CD. Complete the MRI Phantom Transmittal Form and send this with the exam.

Decision Tree for Daily QA Exam:

• If the system fails any test, check coil connections (including top/bottom latch), and coil and phantom positions. Repeat test.

• If the system fails a second time, repeat test with the alternate knee coil.


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• If the system fails with the alternate knee coil, reboot the system with the head coil and SNR phantom (let phantom settle for 3-5 minutes), run Head Coil S/N DIP (Customer QA Menu), and record on the SNR log sheet. If the Head S/N does not pass, repeat the measurement once again. If the Head S/N passes, run the knee coil S/N DIP (let phantom settle for 3 minutes) using the Customer QA Menu and record on the SNR log sheet. If the Knee S/N does not pass, repeat the measurement once again. If the Knee S/N passes, re-test the daily QA exam with the knee coil.

• If the system fails the two Head S/N tests, call Siemens Service and Synarc.

• If the system fails the two Knee S/N tests, try the test on an alternate knee coil. If the system continues to fail the Knee S/N test, call Siemens Service and Synarc.

• If the system still fails the Daily QA exam, call Siemens Service and Synarc.

3.5.2 Weekly Quality Assurance Procedures

• At least once per week run the Siemens S/N test (Options, Customer QA Menu) on the head coil and phantom.

• At least once per week run the Siemens S/N test (Options, Customer QA Menu) on all knee coils and phantom

• Inspect all phantoms for leaks, cracks, or other damage. If problems are encountered, notify Synarc and contact the supplier:

- Siemens for system phantoms; - J.M Specialty Parts for the ACR phantom; - Synarc for the study phantom.

• Inspect the head and knee coils, paying special attention to cable insulation, strain relief fittings, and connectors. Clean and disinfect coil housings. Request replacement RF coil from Siemens and notify Synarc if problems are found.

• Inspect the magnet bore for presence of foreign objects. Clean and disinfect.

• Test the squeeze ball.

• Inspect the magnet room and clean as necessary. Check and clean RF seals (including fingers and jambs) on door and other penetrations.


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3.5.3 Monthly Quality Assurance Procedures

There are four different monthly QA procedures. Each test should be scheduled for a different week of the month. The four tests are:

1. Daily QA, T2 measurement, and 3D volume acquisition with the OAI study phantom. 2. Siemens Body Coil S/N and Calc Artifacts QA 3. Modified ACR Phantom Test Protocol 4. Siemens Preventative Maintenance by Field Service Engineer

3.5.3.1 Knee Coil – OAI Study Phantom The OAI Study Monthly Phantom protocol consists of the Daily QA exam plus a Sagittal T2 map and a Sagittal 3D DESS acquisition of the OAI study phantom. No measurements are done by the site. The exam will be analyzed by SimplyPhysics, and the results reported within 5 working days.

• The knee coil should be positioned at the R60 or L60 location on alternate months.

• Register the exam as follows: For Ohio State Last name: OMQL (left 60) or OMQR (right 60)

Patient ID: 46POAIA

For Pittsburgh Last name: PMQL (left 60) or PMQR (right 60) Patient ID: 58POAIA

For Maryland Last name: MMQL (left 60) or MMQR (right 60) Patient ID: 34POAIA

For Rhode Island Last name: RMQL (left 60) or RMQR (right 60) Patient ID: 10POAIA


“OAIB” as the last four characters in the Patient ID. Continue to increase the number by one for each phantom that is used.

Monthly OAI Study Phantom QA Scan Acquisition and Analysis:

• Run 3-plane localizer

• Axial and Sagittal 2D IW TSE (prescribe as shown for the Daily QA procedure)

• Sag 3D DESS (straight sagittal, no oblique); use scan prescription as shown:


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Scan prescription for Sag 3D DESS

• Sagittal T2 Map sequence (prescribe as shown for Sagittal IW TSE in the Daily QA procedure)

• Send the exam to Synarc on a CD. It can be included with participant exams

on the same CD. Complete the MRI Phantom Transmittal Form and send this with the exam.

• DICOM transfer the exam to SimplyPhysics. If electronic transfer is not feasible, send exam on a CD to SimplyPhysics (5816 Narcissus Ave., Baltimore, MD 21215). Do not delete the exam from the Leonardo system until the results are received.

Decision Tree for Monthly OAI Study Phantom QA Exam:

• SimplyPhysics will evaluate signal, noise, and ghost levels as well as the cylinder inner dimensions in the 2D images, the T2 map, and volume of the sphere in the 3D image stack within 5 business days of receipt of the exam.

• If signal intensity, noise, or ghost levels change from baseline values by more than 10%, SimplyPhysics will request two DQA exams be forwarded at the earliest opportunity. SimplyPhysics will analyze the DQA exam within three working days of receipt of the exam.

• If the inside sphere volume measured from the 3D image acquisition differs from the absolute volume by more than 5%, SimplyPhysics will request a repeat exam at the


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earliest opportunity. SimplyPhysics will analyze the repeat exam within three working days of receipt of the exam.

• If the inside length of the phantom measured from the 3D image acquisition differs from the absolute length by more than 1% (of 125 = 1.25mm), SimplyPhysics will request a repeat exam at the earliest opportunity. SimplyPhysics will analyze the repeat exam within three working days of receipt of the exam.

• The T2 values of the solutions contained within the phantom will be calculated from the multi-echo images. If the calculated values vary from the known values by more than 5 ms, SimplyPhysics will request a repeat exam at the earliest opportunity. SimplyPhysics will analyze the repeat exam within three working days of receipt of the exam.

• If the system fails a repeat exam, the site will be instructed to call Siemens service.

3.5.3.2 Body Coil S/N and Calc Artifacts Tests • These tests use the Siemens Body Loader and Spherical Phantom (D240). Refer to

the instructions in the Siemens Syngo MR Software, Options, Customer QA menu.

• Position body loader on the patient table. Note: this will likely require the assistance of a second person.

• Position the spherical phantom in its holder and insert the assembly into the body loader. Ensure that the arrow on the phantom holder is pointing toward the magnet bore.

• Align loader and phantom with the laser crosshairs.

• Select Options, Customer QA from the operating menu.

• Select the coil from the Active Coil selection list.

• Select the Body S/N DIP checkbox.

• Select the Calc Artifacts checkbox.

• Click on the Start button.

• Record SN value and Pass/Fail results in the Body QA log sheet.

• Note: It is not necessary to send any additional Body Coil S/N and Calc Artifacts test information to Synarc.

Decision Tree for Body Coil S/N and Calc Artifacts Tests:

• If the system fails any one of the tests, check the positions of the phantoms (refer to Customer QA menu instructions) and repeat the exam.

• If the system fails a second time, reboot the system with the head coil and SNR phantom in position, let the phantom settle for 3-5 minutes, run Head Coil S/N DIP (Customer QA Menu), and record on the SNR log sheet. If the Head S/N passes, then re-run the body coil tests. If the system fails the Head S/N test, try once again. If the Head S/N continues to fail, call Siemens Service and Synarc.


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• If the system continues to fail Body S/N after two attempts and after passing the Head S/N, contact Siemens Service and Synarc.

3.5.3.3 Head Coil – ACR Phantom

• The ACR evaluation utilizes a complex cylindrical phantom (inner diameter 148mm, inner length 190mm) with positioning marks and a holder suitable for reproducible use in the head coil.

• Register the exam as follows: For Ohio State Last name: OMMM

Patient ID: 46PACRA

For Pittsburgh Last name: PMMM Patient ID: 58PACRA

For Maryland Last name: MMMM Patient ID: 34PACRA

For Rhode Island Last name: RMMM Patient ID: 10PACRA


“ACRB” as the last four characters in the Patient ID. Continue to increase the number by one for each phantom that is used.

• The ACR phantom and the holder (cradle) should be carefully positioned in the head

RF coil to maintain alignment. The nose label should be up and the chin label should point away from the magnet.

• Landmark on the center of the phantom (which should be aligned to the center of the head coil). Move to isocenter and let settle for 2-3 minutes.

ACR Phantom Monthly QA Scan Acquisition and Analysis:

• Run the Monthly ACR Phantom protocol:

• 3-plane localizer is performed

• Sagittal single plane acquisition is prescribed from isocenter. Two acquisitions are run, one without and one with Large FOV Correction Filter.


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Scan prescription for Axial IW exams

• Prescribe the Axial IW exams from the (first) single slice sagittal acquisition (without the Large FOV filter correction applied). The first of the 11 slices should be aligned with the first low contrast object as shown in the figure below.

• Send ACR exam images to Synarc on a CD. These can be included with participant exams on the same CD. Complete the MRI Phantom Transmittal Form and send this with the exam.


Decision Tree for ACR Phantom Monthly QA Exam:

• SimplyPhysics will evaluate the images based on the following criteria ("Phantom Test Guidance for the ACR MRI Accreditation Program") and report the results to the site within 5 business days of receipt of the exam:

• Geometric Accuracy 1. Inside end-to-end length 148 ± 1.0 mm; 2. Inside diameter 190 ± 1.0 mm.


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• High contrast spatial resolution ≤ 0.9 mm

• Slice thickness accuracy 3 mm ± 1.0 mm

• Slice position error ≤ 2 mm

• Percent Signal Ghosting ≤ 1.0 %

• If the system fails any of these tests, SimplyPhysics will request a repeat exam at the earliest opportunity. SimplyPhysics will analyze the repeat exam within three business days of receipt of the exam.

• If the system fails the repeat exam, the site will be instructed to call Siemens service.

3.5.3.4 Siemens Preventative Maintenance Siemens field engineers will perform preventative maintenance on a monthly basis.

3.5.4 Annual Quality Assurance Procedures

An annual ACR acceptance test must be done using the head coil and the ACR phantom.

• Register the exam as follows: For Ohio State Last name: OAAA

Patient ID: 46PACRA

For Pittsburgh Last name: PAAA Patient ID: 58PACRA

For Maryland Last name: MAAA Patient ID: 34PACRA

For Rhode Island Last name: RAAA Patient ID: 10PACRA


“ACRB” as the last four characters in the Patient ID. Continue to increase the number by one for each phantom that is used.

• The ACR phantom and the holder (cradle) should be carefully positioned in the head

RF coil to maintain alignment. The nose label should be up and the chin label should point away from the magnet.

• Landmark on the center of the phantom (which should be aligned to the center of the head coil). Move to isocenter and let settle for 2-3 minutes.


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ACR Phantom Annual QA Scan Acquisition and Analysis:

• Run the Annual ACR Phantom protocol:

• 3-plane localizer is performed

• Sagittal single plane acquisition is prescribed from isocenter. Two acquisitions are run, one without and one with Large FOV Correction Filter.

Scan prescription for Axial IW exams

• Prescribe the Axial T1W and PD/T2W exams from the (first) single slice sagittal acquisition (without the Large FOV filter correction applied). The first of the 11 slices should be aligned with the first low contrast object as shown by the red arrow in the figure below.

• Prescribe the Axial IW exams from the (first) single slice sagittal acquisition (without the Large FOV filter correction applied) in the same manner as described above.

• Send ACR exam images to Synarc on a CD. These can be included with participant exams on the same CD. Complete the MRI Phantom Transmittal Form and send this with the exam.


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Decision Tree for ACR Phantom Annual QA Exam:

• SimplyPhysics will evaluate the T1W, PD, T2W, and IW images based on the following methodology ("Phantom Test Guidance for the ACR MRI Accreditation Program"), the reporting criteria are more stringent for the OAI than they would be for a clinical exam, and report the results to the site within 5 business days of receipt of the exam:

• Geometric Accuracy 1. Inside end-to-end length 148 ± 1.0 mm; 2. Inside diameter 190 ± 1.0 mm.

• High contrast spatial resolution ≤ 0.9 mm

• Slice thickness accuracy 5 mm ± 0.7 mm for SE sequences; 3mm ± 1.0mm for TSE sequences

• Slice position error ≤ 2 mm

• Percent Signal Ghosting ≤ 2.5 % for SE sequences; < 1.0% for TSE sequences

• If the system fails any of these tests, SimplyPhysics will request a repeat exam at the earliest opportunity. SimplyPhysics will analyze the repeat exam within three working days of receipt of the exam.

• If the system fails the repeat exam, the site will be instructed to call Siemens service.


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4.0 DATA HANDLING PROCEDURES MRIs should be sent to Synarc according to the procedures described in this section.

4.1 Supplies

Synarc will be providing the following supplies to the Clinical Sites: • MRI Procedure Manual • MRI Transmittal Forms (for participant exams) • MRI Phantom Transmittal Forms (for daily, monthly, and annual QA exams) • Quick Reference Guide • Labels for electronic media • Pre-printed air waybills • OAI Study Phantom to be used for daily and monthly QA exams To request more of the study supplies, please photocopy the Supply Order Form (XIII), fill it out clearly, and fax it to Synarc using the fax number on the form. The shipping material is available through the local FedEx office; however, if you need additional pre-printed air waybills, use the Supply Order Form (Appendix XIII). Call the courier if you need additional shipping supplies.

4.2 Data Preparation

All MRIs of the knee and thigh for participants enrolled into the study will be sent to Synarc. All daily QA exams, Study Monthly QA exams, ACR Monthly QA exams, and the ACR Annual QA exam will be sent to Synarc. Complete the MRI Transmittal Form for participant exams and the MRI Phantom Transmittal form for QA exams, keeping a copy for your site records and sending the original to Synarc (see Appendix V for instructions) along with electronic media containing the MRI exam data. All electronic media should be labeled using the pre-printed adhesive labels provided by Synarc (see Appendix VI for instructions). If an MRI exam has been repeated, please use a new Transmittal Form for the repeat exam and be sure to bubble-in “Repeat” field.

4.3 Data Shipping

FedEx is the designated courier for this study. Complete the pre-printed air waybill, keeping a copy for tracking purposes in case a package is lost or delayed. Call your local FedEx office to schedule your package pick-up, taking into account the latest call and pick-up time.


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Collect and ship MRIs to Synarc. All MRIs should be sent as soon as possible to Synarc, to allow for repeats of poor quality exams within 3 weeks of the scheduled visit. MRIs should be sent once per day at the beginning of the study; the shipment schedule may change as the study progresses. Synarc will inform you when the shipment schedule changes. Important: Your site must keep a permanent archive copy of the MRIs. Ship MRIs to Synarc using the pre-printed air waybills. If the air waybills are not available, please complete a blank air waybill with the following information: Alan Fong OAI Synarc Inc. 575 Market Street, 13th Floor San Francisco, CA 94105 USA Telephone: 415-817-7918 Fax: 415-817-8999 Your Internal Billing Reference: 36239SYNFX (This MUST be included.) Use Standard Overnight service. FedEx Third Party Account Number: 252620729


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APPENDIX I MRI Protocol Details 3-plane 2D TSE 3D DESS 2D TSE 3D FLASH 2D MSME Thigh Loc. Thigh Axial Weighting T1W Int T2* Int T1W T2 Map T1W Int Plane 3-plane Coronal Sag Sagittal Cor Sagittal 2-plane

(Coronal, Axial)

Axial

Fat Sat No No WE Yes WE No No No Matrix (phase) 256 307 307 313 512 269 256 384 Matrix (freq) 512 384 384 448 512 384 512 512 No. of slices 21 41 160 37 80 21 12 15 FOV (mm) 200 140 140 160 160 120 400 500 Slice thickness (mm) 5 3 0.7 3 1.5 3 10 5 Skip (mm) 1 0 0 0 0 0.5 0; 300 0 Flip Angle (deg) 40 180 25 180 12 n/a 60 180 TE/TI (ms) 5 29 4.7 30 7.57 10, 20, 30, 40,

50, 60, 70 5 13

TR (ms) 10 3850 16.3 3200 20 2700 10 600 BW (Hz/pixel) 250 352 185 248 130 250 250 199 Chemical Shift (pixels) 1.8 1.3 0 0 0 1.8 1.8 2.2 NAV (NEX) 1 1 1 1 1 1 1 1 Echo train length 1 7 1 5 1 1 1 1 Phase Encode Axis A/P, R/L R/L A/P S/I R/L A/P A/P, R/L A/P Phase Partial Fourier (8/8 = 1) 1 1 1 1 1 1 1 1 Readout Partial Fourier (8/8 = 1) 1 1 1 1 1 1 1 1 Slice Partial Fourier (8/8 = 1) 1 1 0.75 1 0.75 0.75 1 1 Options: elliptical k-

space filter and large FOV

filter

elliptical k-space filter,

elliptical sampling, large FOV

filter

elliptical k-space filter

and large FOV filter

elliptical scanning, elliptical k-space filter, larger FOV

filter

elliptical k-space filter

and large FOV filter

elliptical k-space filter and large FOV

filter; ascending slice order, 2

concatenations, no FlowComp, std

shim Distance Factor (%) 50 0 0 0 0 16 0; 300 0 Phase Oversampling 0 20 0 40 0 0 0 0 Slice Oversampling 0 0 10 0 0 0 0 0 Phase Resolution 50 80 80 70 100 70 50 62.5 Averaging Technique Short Term Short Term Short Term Short Term Short Term Short Term Short Term Short Term Gradient Rise Time Fast Fast Fast Fast Fast Fast Normal Normal RF Amplitude Normal Normal Fast Normal Fast Normal Low SAR Normal X-Resolution (mm) 0.391 0.365 0.365 0.357 0.313 0.313 0.781 0.977 Y-Resolution (mm) 0.781 0.456 0.456 0.511 0.313 0.446 0.781 0.814 Calc time (min) 2.7 3.4 11.0 4.7 10.2 9.1 1.5 3.8 Scan time (min) 0.5 3.4 10.6 4.7 8.6 10.6 1.5 6.4


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APPENDIX II MRI QA Protocol Details


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APPENDIX III Backup and Restore Protocols Follow the procedures below in order to backup and restore protocols, including prototype pulse sequences and .edx files. OAI MRI protocols will be provided on CD. The source CD should be loaded into the scanner sequence library in order to speed up the examination and limit the potential of human error. Backup Procedure:

1. Open Exam Explorer 2. In the USER stored protocols, Locate and highlight Protocol to export (such as

Head/Routine) a. Click Object/Export b. A pop up will appear c. Place file into directory C:\ExamDBbackup d. Check option for Export Sequences e. Click on Export

3. Place CD in "S" drive (white drive) 4. Open Options/Local Service 5. Click Back-up/Restore

a. In first pull down menu, choose Back-up b. In second menu, choose Drive "S" c. In third menu, choose ExamDB d. Click GO

Restore Procedure:

1. Place CD in "R" drive (black drive) 2. Open Options/Local Service 3. Click Back-up/Restore

a. In first pull down, choose Restore b. In second menu, choose Drive "R" c. In third menu, choose ExamDB d. Click GO

This will place the EDX in the directory C:\ExamDBOpen Exam Explorer 4. Click on USER

5. Click on OK 6. Click on .edx file you need to import 7. Select Import 8. Convert and import


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APPENDIX IV Quick Reference Guide


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APPENDIX V

Instructions for Completing the MRI Transmittal Form and MRI Phantom Transmittal Form

To complete the MRI Transmittal Form and the MRI Phantom Transmittal Form properly, follow the guidelines below.

Participant Information (MRI Information on MRI Phantom Transmittal Form)

• Record the participant demographic information including the 7-digit OAI Participant ID and 4-letter Acrostic.

• Check the box for the appropriate visit.

• Check the box for the appropriate cohort.

MRI Information

• For phantom data submissions, enter the “Patient ID” from the scan as the OAI Phantom ID (site code + P + OAI or ACR + A) and enter the “Last name” from the scan as the Acrostic (site letter + DQR / DQL, etc).

• Complete date of MRI exam. Enter the dates using the date format: MM/DD/YYYY (e.g., 02/27/2003 for February 27, 2003).

• Check repeat box to indicate if exam is a repeat requested by Synarc.

• Complete the OAI MRI Tech ID # of the MRI technologist who acquired the data.

• For phantom data submissions, check the type of phantom exam being submitted.

• Check the NA box for a particular sequence if that sequence was not acquired. Be sure to give a reason in the comment field for any sequences that are not acquired except for the left knee Cor T1 3D VIBE and the left knee Sag T2 Map.

• Document any relevant comments (these may include, but are not limited to, positioning or scheduling issues).

Data Shipment to Synarc

• Document the air waybill number of the package.

• Number each CD in the package and indicate the appropriate CD number on each Transmittal Form.

• Enter Staff ID # after checking for completeness and correctness.

• Keep copy of the transmittal form at site for your records.

- Please always include a transmittal form with every submission of participant or phantom MRIs.


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REMINDERS

• Print CLEARLY – all writing needs to be legible.

- Use black ink. Avoid making stray marks. Completely darken the bubbles.

- Print in capital letters. Print only one letter or number per box. Keep the letter or number completely inside the box.

- Do not use white-out. Cross out the wrong answer. Indicate the correct answer. Initial and date the correct answer.

• The original, properly completed MRI Transmittal Form must be sent with the MRIs to Synarc.

• Retain a copy of each form for your files along with a copy of the courier’s air waybill when the MRIs are shipped.

• The Clinic Coordinator will receive an email confirmation (Incremental Site Report) from Synarc, acknowledging receipt of the exams and providing feedback on the exam quality within 5 business days of receipt of data at Synarc. If you have not received this report when you expect to (allowing for transit time from site to Synarc), please contact Synarc:

Contact: Alan Fong Tel. 415-817-7918 Fax 415-817-8999

Email: [email protected]


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APPENDIX VI

Instructions for Labeling the Electronic Media If submitting data on media, transfer the exams to a CD from either the scanner console or the Leonardo Workstation. When prompted by the software to label the CD, enter the CD Number. This number should consist of the site code (O, P, M, or R for Ohio, Pittsburgh, Maryland, or Rhode Island, respectively) plus the date of creation in yyyymmdd format, plus “A”, “B”, “C”, … The first CD written on a particular date is designated “A”, the second “B”, and so on. For example: P20040101A

1. Pre-printed header identifies the study and modality.

2. CD # : Complete the CD number according to the convention described above.

REMINDERS

• The participant information recorded on the media label, MRI header, MRI Transmittal Form, and MRI Tracking Form must be identical.

• Use one label per electronic media. Affix label to the media, not to the case. Do not wrap label around the edge of the media.

• To protect participant confidentiality, no personal identifiers such as names, medical records, or social security numbers are to be included in any headers or labels.

The CD number consists of the site code, creation date, plus sequence identifiers “A”, “B”, “C”, … The first three digits of the year are already pre-filled on the labels.

1 OAI MRI

2

CD #: 2 0 0 x y y y y m m d d

OAI MRI

CD # ____________


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APPENDIX VII

MRI Transmittal Form


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APPENDIX VIII

MRI Phantom Transmittal Form

MRI Procedure Manual for Examinations of the Knee and Thigh ___________________________________________________________________________OAI Protocol

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Appendix IX

OAI MRI Parameter Log

Enrollment

Exam Tech. ID # Comments

MRI Date

Right Knee

Left Knee

Thigh

12 Month


MRI Date

Right Knee

Left Knee

Thigh

This Parameter Log should be photocopied or printed from the OAI website (under the Documents and Forms link) and completed for each study participant. It should then be filed in the participant’s chart and referenced at subsequent participant visits (the form will need to travel with the participant to the MRI facility to be completed by the technologist and then back to the clinic for filing).

Do NOT send this form to Synarc.

OAI Participant ID#: ___ ___ ___ ___ ___ ___ ___ Acrostic: ___ ___ ___ ___

MRI Procedure Manual for Examinations of the Knee and Thigh ________________ OAI Protocol

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OAI MRI Parameter Log 24 Month


MRI Date

Right Knee

Left Knee

Thigh

36 Month


MRI Date

Right Knee

Left Knee

Thigh

48 Month


MRI Date

Right Knee

Left Knee

Thigh

OAI Participant ID#: ___ ___ ___ ___ ___ ___ ___ Acrostic: ___ ___ ___ ___


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APPENDIX X Daily QA Logsheet

Coil Serial Number

Siemens Phantom

(Isocenter)

S/N

Coil Position

(R/L)

Inner Sphere Signal

Inner Sphere

SD

Noise in Freq.

Direction

Noise in Phase

Direction (Ghosting)

Cylinder Horizontal

(Axial)

Cylinder Vertical (Axial)

Cylinder Length

(Sagittal) Comments

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday/Sunday

OAI Phantom at R60 or L60

Extremity Coil Daily QA: Week of __ __ / __ __ / 2 0 0 __

This logsheet should be photocopied or printed from the OAI website (under the Documents and Forms link) and completed for the daily QA procedures (one sheet per week). It should be filed at your site.

Do not send this form to Synarc.


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APPENDIX XI Weekly QA Checklist

Head Coil S/N

Date

Siemens Head Coil & Phantom at Isocenter

Siemens Phantoms

ACR Phantom

OAI Phantom

Magnet Bore

Magnet Room

Doors, RF Seals Comments

1st Week

2nd Week

3rd Week

4th Week

Inspection and Cleaning (v)

Weekly QA: Month of __ __ / 2 0 0 __

Backup Extremity Coil #1 S/N

Serial #:

Backup Extremity Coil #2 S/N

Serial #:

This logsheet should be photocopied or printed from the OAI website (under the Documents and Forms link) and completed for the weekly QA procedures (one sheet per month). It should be filed at your site.

Do not send this form to Synarc.


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APPENDIX XII Monthly QA Logsheet

Monthly QA: Month of __ __ / 2 0 0 __

Date

Performed Forwarded to

Synarc (√) CD # S/N Result Comments

OAI Phantom Exam

NA

Body Coil QA/Calc Artifacts

ACR Phantom Exam

NA

Siemens Prev. Maintenance

NA

This logsheet should be photocopied or printed from the OAI website (under the Documents and Forms link) and completed for the monthly QA procedures (one sheet per month). It should be filed at your site. Do not send this form to Synarc.


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APPENDIX XIII

MRI Supply Order Form

Please fill out a copy of this form (on next page) and keep the blank original in the manual.


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OAI MRI Supply Order Form Please indicate quantity of each MRI supply needed and fax this form to:

Alan Fong Fax: 415-817-8999

Attention: OAI Project Team

Supplies will be sent to the following location: Please update contact name and address information as needed.

Site #: Attn: Address:

Quantity

Media labels

Pre-printed air waybills

CDs

CD jewel cases