ACRIN 6695/ GOG-0262 Imaging Manual

A Randomized Phase III Trial Of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel In Combination With Carboplatin With Or Without Concurrent And Consolidation Bevacizumab (NSC #704865, IND#7921) In The Treatment Of

Primary Stage III or IV Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer

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Table of Contents

Study Schema 3 Letter of Introduction 4 Imaging Qualification and Scanning Procedures 5 CT Scanning Protocol, Contrast Dose and Radiation Dose 7 Tumor Eligibility 11 Image Submission 14 Image Transmittal Worksheet Instructions 17 Image Transmittal Worksheet 18 Quality Control Procedures 20 Z5 Imaging Query 21 Target Lesion Guide 22

Technologist Tips ACRIN 6695 27 Appendix 28

I. Creating, Anonymizing, and Importing Screen Captures

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ACRIN 6695 Study Schema

Perfusion CT timepoints

T0 Imaging: The baseline perfusion imaging (T0) must be performed less than 28 days before start of either adjuvant and neoadjuvant chemotherapy. For patients receiving adjuvant chemotherapy, T0 Imaging must be performed at least 3 weeks after surgery. The baseline TO perfusion imaging may be performed at the same session as the baseline RECIST radiographic assessment of disease.

T1 Imaging: T1 Imaging must be performed between day 18 and day 21 of Cycle 1 chemotherapy. T2 Imaging: T2 Imaging must be performed on day 8 to day 10 of Cycle 2 chemotherapy.

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Letter of Introduction Dear Imaging Staff, This Imaging Manual contains the image acquisition instructions for the ACRIN 6695 trial: “A Randomized Phase III Trial of Every-3-Weeks Paclitaxel Versus Dose Dense Weekly Paclitaxel in Combination With Carboplatin with or without Concurrent and Consolidation Bevacizumab (NSC #704865, IND#7921) in the Treatment Of Primary Stage III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer”. To successfully meet the study objectives, it is critical that the perfusion CT images are acquired according to the imaging protocol detailed in this manual. Quality Control (QC) review of the images will be performed by the ACR Imaging Core Laboratory. This review will be performed in a timely fashion as part of ACRIN standard operating procedures. If any protocol deviations or technical issues are identified during the review, the Imaging Specialist will contact the site to provide feedback expeditiously. This will allow the site to make the necessary adjustments early in the conduct of the study. The ACRIN 6695 Imaging Team wishes to thank you in advance for your diligence in adhering to the procedures described in this manual to ensure the integrity of the image data collected for the study. Please do not hesitate to contact the ACRIN 6695 Imaging Team or the Principal Investigators if you have any questions. Sincerely, Chaan S. Ng, MD ACRIN 6695 Radiologist M.D. Anderson Cancer Center, Houston, Texas Ting Yim Lee, PhD ACRIN 6695 Medical Physicist Roberts Research Institute, London, Ontario, Canada

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Imaging Qualification and Scanning Procedures

Qualification Requirements Overview 1. CT Scanner Requirements 2. Perfusion CT Qualification Process 3. Qualification Imaging Scan

1. CT Scanner Requirements A multislice CT (64 or more slice) scanner capable of imaging a 2.8cm or wider section of the abdomen/pelvis repeatedly every 1-3 seconds for a period up to 2 minutes is required. 2. Perfusion CT Qualification Process ACRIN qualification of the perfusion CT scanner is required prior to enrollment of study participants. This qualification is independent and separate from the ACR or ICACTL accreditation requirement. Sites are required to submit two (2) phantom series: one water section and one high contrast spatial resolution section for review and approval by the ACR Imaging Core Laboratory. This will require the use of the quality control phantom supplied by the CT scanner vendor. Sites are required to scan the water and high contrast spatial resolution sections of the phantom using the protocol appropriate to your site. PLEASE NOTE: the FDA requires all vendors to supply a quality control phantom for their CT scanners consisting of a water section, a high contrast spatial resolution section, and other features. The ACR Imaging Core Laboratory will evaluate two quality control phantom series with respect to the following parameters: Diameter of the Water section:

• Dose-length product of the scan; • Spatial and temporal uniformity of the mean CT number within one (1) cm

diameter region in the water section; • Spatial and temporal uniformity of the standard deviation of CT numbers within

one (1) cm diameter region in the water section; • The evaluated parameters should be within ± 15% deviation of vendor

specifications.

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High contrast spatial resolution section: • the entire dynamic series will be averaged; • resolution limits in lp·cm-1 will be evaluated visually; • the limit should be within ± 15% of vendor specifications.

3. Qualification Imaging Scan The first imaging dataset of the first enrolled patient will be the final qualification step for the site.

Qualification scans will be reviewed at the ACR Imaging Core Laboratory to ensure high quality images and compliance with the protocol. The site PI, research associate, and lead technologist will receive feedback of this review and will be notified if the scans are inadequate. A form explaining necessary corrective actions will be e-mailed to these individuals.

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CT Scanning Protocol, Contrast Dose and Radiation Dose Note: In the following description, interscan delay refers to the time interval from the end of a scan to the start of the immediately following scan. It is not the time interval between the start of a scan to the start of the immediately following scan. For example, if the interscan delay is 1.8 s and the rotation period is 1 s, then the start-to-start of two consecutive scans will be 1.8 + 1.0 = 2.8 s. Additional Note: Every patient will have an abdominal strap put on at the mid-lower abdominal using gentle pressure to decrease the motion of the abdomen due to breathing. 64-Slice CT Scanner with 4 cm Wide Detector Array without Toggling Table Mode Scan Protocol: two-phase dynamic contrast enhanced scan Scan delay relative to injection of contrast : 4-5s. 1st phase: 24 scans @120 kVp, 50 mA, 8 x 5 mm, 1s rotation period, 1.8 s interscan delay

2nd phase: 8 scans @ 120 kVp,50 mA, 8 x 5 mm, 1 s rotation period, 14 s interscan delay

Time interval between 1st and 2nd phase is 15 s. This time is the time interval between the end of the last scan in the 1st phase and the start of the first scan in the 2nd phase.

Scan duration: 184 s Axial Field of View: 40 mm Scan and Display Field of View: 400 mm suggested (Each institution should use their SOC CT imaging to display the body habitus) Contrast dose: 0.8ml•kg -1 of body weight up to maximum of 70 ml of contrast at a concentration of 300 – 370 mgI•ml -1, Injection rate: The preferred injection rate is between 2-4 ml•sec-1 injected via adequate venous access starting at the same time as scanning. Please choose the maximum rate as per your institutional SOC. Injection starts 4-5 s before the start of the scanning Effective dose: 7.2 mSv Skin dose: 150 mGy 64-Slice CT Scanner with 4 cm Wide Detector Array with Toggling Table Mode Scan Protocol: two-phase dynamic contrast enhanced scan using shuttle mode that toggles (cycles) the patient table alternately between two contiguous 4 cm locations: Scan delay relative to injection of contrast : 4-5s. 1st phase: 24 cycles @120 kVp, 125 mA, 16 x 5 mm, 0.4 s rotation period

2nd phase: 8 cycles @ 120 kVp, 125 mA, 16 x 5 mm, 0.4 s rotation period with a 13.2 s delay between cycles

Time interval between 1st and 2nd phase is 15 s. This time is the time interval between the end of the last scan in the 1st phase and the start of the first scan in the 2nd phase.

Scan duration: 184 s

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Axial Field of View: 80 mm Scan and Display Field of View: 400 mm suggested (Each institution should use their SOC CT imaging to display the body habitus) Contrast dose: 0.8ml•kg -1 of body weight up to maximum of 70 ml of contrast at a concentration of 300 – 370 mgI•ml -1, Injection rate: The preferred injection rate is between 2-4 ml•sec-1 injected via adequate venous access starting at the same time as scanning. Please choose the maximum rate as per your institutional SOC. Injection starts 4-5 s before the start of the scanning Effective dose: 14.3 mSv Skin dose: 150 mGy 128-Slice CT Scanner with 80 mm Wide Detector Array without Toggling Table Mode Scan Protocol: two-phase dynamic contrast enhanced scan Scan delay relative to injection of contrast : 4-5s.

1st phase: 24 scans @120 kVp, 50 mA, 16 x 5 mm, 1s rotation period, 1.8 s interscan delay

2nd phase: 8 scans @ 120 kVp,50 mA, 16 x 5 mm, 1 s rotation period, 14 s interscan delay

Time interval between 1st and 2nd phase is 15 s. This time is the time interval between the end of the last scan in the 1st phase and the start of the first scan in the 2nd phase.

Scan duration: 184 s Axial Field of View: 80 mm Scan and Display Field of View: 400 mm suggested (Each institution should use their SOC CT imaging to display the body habitus) Contrast dose: 0.8ml•kg -1 of body weight up to maximum of 70 ml of contrast at a concentration of 300 – 370 mgI•ml -1, Injection rate: The preferred injection rate is between 2-4 ml•sec-1 injected via adequate venous access starting at the same time as scanning. Please choose the maximum rate as per your institutional SOC. Injection starts 4-5 s before the start of the scanning Effective dose: 14.3 mSv Skin dose: 150 mGy 256-Slice CT Scanner with 120 mm Wide Detector Array without Toggling Table Mode Scan Protocol: two-phase dynamic contrast enhanced scan Scan delay relative to injection of contrast : 4-5s

1st phase: 24 scans @120 kVp, 50 mA, 20 x 5 mm, 1s rotation period, 1.8 s interscan delay

2nd phase: 8 scans @ 120 kVp,50 mA, 20 x 5 mm, 1 s rotation period, 14 s interscan delay

Time interval between 1st and 2nd phase is 15 s. This time is the time interval between the end of the last scan in the 1st phase and the start of the first scan in the 2nd phase.

Scan duration: 184 s

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Axial Field of View: 100 mm Scan and Display Field of View: 400 mm suggested (Each institution should use their SOC CT imaging to display the body habitus) Contrast dose: 0.8ml•kg -1 of body weight up to maximum of 70 ml of contrast at a concentration of 300 – 370 mgI•ml -1, Injection rate: The preferred injection rate is between 2-4 ml•sec-1 injected via adequate venous access starting at the same time as scanning. Please choose the maximum rate as per your institutional SOC. Injection starts 4-5 s before the start of the scanning Effective dose: 17.8 mSv Skin dose: 150 mGy 320-Slice CT Scanner with 160 mm Wide Detector Array Scan Parameters: two-phase dynamic contrast enhanced scan Scan delay relative to injection of contrast : 4-5s.

1st phase: 24 scans @120 kVp, 50 mA, 20 x 5 mm, 1s rotation period, 1.8 s interscan delay

2nd phase: 8 scans @ 120 kVp,50 mA, 20 x 5 mm, 1 s rotation period, 14 s interscan delay

Time interval between 1st and 2nd phase is 15 s. This time is the time interval between the end of the last scan in the 1st phase and the start of the first scan in the 2nd phase

Scan duration: 184 s Axial Field of View: 120 mm Scan and Display Field of View: 400 mm suggested (Each institution should use their SOC CT imaging to display the body habitus) Contrast dose: 0.8ml•kg -1 of body weight up to maximum of 70 ml of contrast at a concentration of 300 – 370 mgI•ml -1, Injection rate: The preferred injection rate is between 2-4 ml•sec-1 injected via adequate venous access starting at the same time as scanning. Please choose the maximum rate as per your institutional SOC. Injection starts 4-5 s before the start of the scanning Effective dose: 21.4 mSv Skin dose: 150 mGy The effective dose of a CT Perfusion scan of the abdomen based on the above protocols on 64-320 slice CT scanners vary from 7.2 to 21.4 mSv as the axial field of view increases from 40 to 120 mm. In the following we use the effective dose, 14.3 mSv, of a CT Perfusion study covering 8 cm of the abdomen as the reference dose in this protocol. In comparison, the effective dose for a CT abdomen scan with contrast is 14.8 mSv based on a European survey of CT studies in 2001 (72). The study will include the following additional CT scans and perfusion studies that are not part of the normal care (indicated by **) as well as regular contrast enhanced abdomen CT scan required for normal care (indicated by *):

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The effective dose and skin dose in the above table are estimated using the dose-length products for the scanning protocols described above on a GE Healthcare VCT/HD750 scanner. These estimates are not expected to change significantly with other vendor’s scanners. We propose to have a set-up phase wherein we will test the CT scanner of each participating site to ensure that the doses are not significantly different from those listed in the above table and that the imaging quality at those dose levels are similar to that obtainable with a GE scanner. The risks of cancer induction and deaths from all CT scans (research plus normal care) for patients IN the reproducibility sub-study are listed in the table. This is the case with the highest effective dose and skin dose, therefore the risks for patients not in this sub-study will be smaller. For comparison the same risks in the general (female) population not exposed to radiation are also listed in the table (73). As can be seen, the induced risks of cancer induction and deaths are 1.5 and 2.1% respectively of those occurring in the general (female) population not exposed to radiation. The risks to GOG patients evaluated by an additional (outside of normal care) abdominal non-enhanced CT scan for consideration of enrolment in the concept protocol but excluded because tumor is smaller than 1 cm diameter will be approximately one-quarter of those for patients enrolled in the concept protocol.

Imaging Schedule with effective and skin dosage Effective

Dose (mSv)

Skin Dose

(mGy) T0: Baseline (prior to chemotherapy) **Non-enhanced CT abdomen scan at regular dose to determine eligibility (tumor greater than 1 cm diameter 14.8 27 **Localization non-enhanced CT abdomen scan at one-third regular dose to define limits of CT Perfusion study 4.9 9 **CT Perfusion study with 8 cm coverage 14.3 150 *Contrast enhanced CT abdomen scan 14.8 27 T1: (after 1 cycle of chemotherapy) **Localization non-enhanced CT abdomen scan at one-third regular dose to define limits of CT Perfusion study 4.9 9 **CT Perfusion study with 8 cm coverage 14.3 150 **Repeat CT Perfusion study with 8 cm coverage@ 14.3 150 T2: (after one week of cycle 2 of chemotherapy) **Localization non-enhanced CT abdomen scan at one-third regular dose to define limits of CT Perfusion study 4.9 9 **CT Perfusion study with 8 cm coverage 14.3 150

Total ALL scans (research plus normal care) for patients NOT in the reproducibility sub-study 87.2 531 ALL scans (research plus normal) for patients in the reproducibility sub-study 101.5 681 ONLY research scans for patients IN the reproducibility sub-study 86.7 654

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Tumor Eligibility

Perfusion CT with Iodinated Contrast Patients who consent and are enrolled in imaging study will be assessed for the presence of a perfusion imaging target lesion at T0 concurrent with the first radiographic assessment of disease within 28 days before initiating protocol therapy. The following criteria for the potential target lesion must be met at the participating institution:

• a minimum length of 1 (one) cm in both the long and short axis will be determined at the local site;

• at least half the potential target lesion should have an attenuation of at least 10 HU;

Besides the above two criteria, the potential target lesion selected by the participating institution will be evaluated at the ACR Imaging Core Lab for meeting the following additional criterion in the T0 perfusion scan:

• at least half the potential target lesion should have an maximum enhancement of at least 5 HU

Only patients who have the appropriate target lesion according to the above criteria will go on to the T1 and T2 perfusion CT scans. Those without a target lesion will continue on the GOG-0262 treatment study and will be considered off study for ACRIN 6695.

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Protocol at Baseline T0 perfusion imaging Eligibility scan to identify potential target lesion: a non-enhanced CT scan of the abdomen and pelvis using the institutional standard of care scanning protocol without intravenous contrast will be performed Potential target lesion is deemed eligible if the tumor is at least 1 cm in size in both the long and short axis. At least half the potential target lesion should have an attenuation of at least 10 HU. Localization scan: A localization scan is required if the patient has been removed from the CT scanner table after the eligibility scan or their conventional CT was performed previously. The abdomen and pelvis are to be scanned as in the eligibility scan but with a limited radiation dose technique. A 4-12 cm section of the abdomen /pelvis covering the maximal cross-section of or the whole potential target lesion is defined from this scan or the eligibility scan. Perfusion CT scan: A perfusion scan of the 4-12 cm section of the localized abdomen/pelvis will be performed. Enhanced CT scan: a contrast enhanced CT scan of the abdomen and pelvis using the institutional standard of care scanning protocol for radiographic assessment of disease (see Section 7.1 Table and Section 8.2). This scan is required if the patient does not previously have a contrast enhanced scan at the time of the T0 Perfusion scan T1 Perfusion CT Scan Localization scan: the abdomen and pelvis are scanned as in the localization scan at T0. This scan is used to locate the same 4-12 cm section of the abdomen /pelvis that is scanned with the perfusion protocol at T0. Perfusion CT scan: a perfusion scan of the 4-12 cm section of the abdomen/pelvis localized above is performed as in T0 Repeat Perfusion CT scan: for subjects enrolled into the reproducibility arm, the perfusion CT scan is repeated after a wait of 10 minutes. The reproducibility perfusion CT scan will be performed on a subset of 15 patients. The ACR Imaging Core Laboratory will communicate with the local sites to coordinate the reproducibility perfusion CT. T2 Perfusion CT Scan Localization scan: the abdomen and pelvis are scanned as in the localization scan at T0. This scan is used to locate the same 4-12 cm section of the abdomen /pelvis that is scanned with the perfusion protocol at T0. Perfusion CT scan: A perfusion scan of the 4-12 cm section of the abdomen/pelvis localized above is performed as in T0

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Central Read of Perfusion CT parameters The kinetic analysis of the perfusion CT scan will be performed centrally at the ACR Imaging Core Laboratory to derive tumor functional perfusion parameters including: vascularity or blood volume (BV); perfusion or blood flow (BF); mean transit time (MTT); and microvascular permeability or permeability surface area product (PS).

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Image Submission

I. TRIAD

Each participating site is required to submit CT images to the ACR Imaging Core Laboratory. The preferred image transfer method is via TRIAD, which is the image acquisition and management software developed by the American College of Radiology Imaging Network (ACRIN). In brief, the TRIAD-OA offers a web-based software solution which allows sites participating on this trial to access a secure method to review and submit clinical trial information by anonymizing, encrypting and non-destructively compressing the images transferred to the ACRIN database in Philadelphia.

1. Preparing for TRIAD Installation A. Identify the necessary personnel: Prior to scheduling a time with the ACR site technical specialist, please identify the following key TRIAD personnel contacts:

• The TRIAD user(s): individual(s) who will conduct the transfer and/or review of images using TRIAD. These individuals will need to register a TRIAD account at: https://triad.acr.org/Web/UserAccount/Register.aspx

• IT Administrator(s): individual(s) that will participate in the installation and basic testing of the TRIAD software.

• PACS Administrator(s): individual(s) who will transfer the case images internally from a c-store based scanner to the machine running TRIAD.

B. Designate a Computer for TRIAD use: Identify the computer that will be used to run the TRIAD software (this machine does not need to be used solely for TRIAD). Please review the hardware requirements (listed below) with your IT department to ensure the selected computer meets the minimum requirements. User guides are also located on the TRIAD website at: https://triad.acr.org/Learning.htm C. Confirm User Permissions and Network/Connectivity permissions:

• To install the TRIAD software on the designated computer, an individual with administration rights to the machine must be present during the TRIAD installation. If a shared login is nonexistent on the machine

Please note current TRIAD users must contact TRIAD support to be linked to the ACRIN 6695 trial before you are

able to submit any images via TRIAD.

For TRIAD installation, please call 215-940-8820 or e-mail TRIAD-Support@acr.org.

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chosen for TRIAD, the software must be configured under the logon of the person who will be submitting or reviewing images. The installation is user specific and does not install for all users.

• Please make sure that the necessary connectivity permissions are in place to allow the DICOM transfer of images from the PACS scanner to the TRIAD designated machine. Please make sure that you are allowed to transfer electronic files from the site via the Internet. This ability is needed to submit images from the TRIAD server to the ACRIN HQ Central Server. Please make sure that the designated computer has the necessary firewall permissions to allow access to Citrix “GoToMeeting” and will ne needed for you to received remote assistance from a TRIAD site technical analyst.

Please note the website for go to meeting: https://www1.gotomeeting.com/t/URL/g2m/joingotomeeting?Target=/m/join_gotomeeting.tmpl D. Communicate With Your IT organization: Please forward the information below to your IT group to confirm that the selected computer meets Triad’s minimum requirements prior to scheduling a TRIAD technical specialist appointment.

1. System HARDWARE Requirements for a TRIAD Installation • Model: PC • Processor: Intel P-IV 3GHZ minimum; Intel Core Duo 2 GHZ is

recommended • RAM 1 GB is minimum; 4GB is recommended • HDD: 200 MB for Rich client GUI client application up to 22GB-

for local image cache, the size required will depend on the amount of images stored by the system TRIAD site server HDD depends on the amount of images received from the scanner before they are sent to TRIAD. Image Storage 10 GB minimum; 200GB is recommended.

2. System SOFTWARE Requirements for a TRIAD Installation:

• Microsoft Windows XP SP3 and or Windows Server 2003 SP2

Operating systems • Microsoft .NET Framework 3.5. This can be downloaded and

installed prior to Triad installation from http://www.microsoft.com/downloads/details.aspx?familyid=AB99342F-5D1A-413D-8319-81DA479AB0D7&displaylang=en

• MS SQL 2005 Express This will need to be installed and configured by an ACR site technical specialist

3. System NETWORK Requirements for a TRIAD Installation:

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• For all traffic except image transfer (e.g. metadata search, security attributes exchange, etc.) the minimum client Internet connection speed should be at least 128kbps. For image transfer, additional Internet connection bandwidth of at least 256 kbps is required. Client connection speed of at least 1 Mbps is suggested.

• Speed between TRIAD Site Server and Internet should be at least 256 kbps. Client connection speed of at least 1 Mbps is suggested.

• Internet channel bandwidth of TRIAD Web Server and TRIAD application server should be at least 256 Kbps x MAX number of online users sending or receiving data simultaneously.

• ACR Server side components should be connected through fully switched fabric with full-duplex links with a speed of at least 1Gbps.

E. Scheduling TRIAD Installation If you feel your site is ready to proceed with the TRIAD installation, please call 215-940-8820 or submit an e-mail to TRIAD-Support@acr.org. Please include the following information in your e-mail: our site name and number, study number, preferred installation date and time, names of individuals participating in the installation and their contact information.

II. CD/DVD media via mail The other option for image submission includes submitting images via a CD/DVD and ship to the ACRIN Imaging Core Laboratory. Mailing address: American College of Radiology Imaging Core Laboratory MRI/CT Core Laboratory ATTN: ACRIN 6695 1818 Market Street Suite 1600 Philadelphia, PA 19103 If you have any questions, please contact the ACRIN 6695 Imaging Team: Cyndi Price, RT (R)(MR): phone: 215-940-8863 email: cprice@acr.org Joseph Bauza, RT (R)(CT) phone: 215-940-8886 email: jbauza@acr.org Sandy Toland-Cary, RT (R)(MR) phone: 215-940-8870 email:scary@acr.org

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Image Transmittal Worksheet Instructions The Imaging Transmittal Worksheet (ITW) is available in the Imaging Materials section on the ACRIN 6695 protocol-specific webpage: http://www.acrin.org/PROTOCOLSUMMARYTABLE/PROTOCOLACRIN6695/6695IMAGINGMATERIALS.aspx 1. The CT exams must be submitted to American College of Radiology Imaging

Network (ACRIN) after each protocol-specified time point. Each imaging submission must include a completed and signed Image Transmittal Worksheet (ITW) for each participant on the study. Please fax or mail along with CD/DVD media to:

Fax: 215-923-1737

American College of Radiology Imaging Core Laboratory ATTN: ACRIN 6695 1818 Market Street

Suite 1600 Philadelphia, PA 19103

Please keep a copy of the ITW within the study participant’s records 2. The ITW must be completed in its entirety and signed by the person completing the

worksheet. Studies submitted by mail (CD or DVD) must contain a printed ITW in the mailed package.

3. An ACRIN Core Laboratory Imaging Specialist will review the ITW to confirm:

a. The number of series/images identified as being submitted on the ITW actually arrived at ACRIN;

b. The appropriate identifying/de-identified information was included for the imaging study.

4. Please make sure the signature and email address are legible. The person that

completes and signs the image transmittal form will receive feedback regarding image transmission discrepancies.

For further information or questions regarding the ITW, please contact the ACRIN Imaging Core Laboratory.

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Quality Control Procedures The ACRIN 6695 protocol explicitly requires participating centers to meet technical specifications for the CT scanners for data uniformity and image quality. Additionally, specific parameters for image acquisition are outlined in the protocol and provided in this manual. ACRIN will provide ongoing quality control through the ACRIN Imaging Core Laboratory. Specifically, the ACRIN Imaging Core Laboratory will conduct quality control evaluations on all images to help centers maintain trial grade quality. The ACR Imaging Core Laboratory Specialist will provide feedback to sites, especially during early trial imaging to ensure high-quality images. However, repeat of imaging will not be requested once the trial is under way. Furthermore, the imaging manual contains specific language for image capture (how to scan) and for diagnostics (how to read), with specific imaging submission requirements. If the Specialist identifies that images or image-related data are missing, inaccurate, or inconsistent with the imaging protocol, sites are notified through the following process:

1. An imaging query describing the problem will be e-mailed to the study coordinator. Such a query is referred to as a Z5 form (please see example on the following page).

2. The site should resolve the problem as quickly as possible and must maintain a

hard copy of the completed and signed query at the site.

3. A site will receive three reminders to resolve a query. After that time, an outstanding query is reported to the trial leadership for assistance with resolution.

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ACRIN 6695 - Z5 Imaging Query

IMPORTANT: The case listed above from your institution is incomplete and/or requires a clarification.

Please sign and date this form and return to ACRIN via Email or FAX (215) 923-1737

If imaging is incomplete, please forward all missing data within 5 days

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TARGET LESIONS: Desirable Below are representative desirable target lesion images. 4 cm PELVIC IMPLANT

2.5 cm PELVIC SIDEWALL NODE

• Well defined solid lesions

• Larger than 2 to 3cm, if possible

• In locations which will be relatively stationary during the respiratory cycle eg in retroperitoneum, pelvic sidewalls

• Well defined solid lesions

• Larger than 2 to 3cm, if possible

• In locations which will be relatively stationary during the respiratory cycle eg in retroperitoneum, pelvic sidewalls

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2.5 cm RETROPERITONEAL NODE 4 cm HEPATIC/PERIHEPATIC IMPLANTS

• Well defined solid lesions

• Larger than 2 to 3cm, if possible

• In locations which will be relatively stationary during the respiratory cycle eg in retroperitoneum, pelvic sidewalls

The lesions are in a location subject to motion, but are well defined and >3cm.

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4 cm PERITONEAL IMPLANT

The lesion is in a location subject to motion, but is relatively well defined and >3cm.

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TARGET LESIONS: Suboptimal

Below are representative suboptimal target lesion images. If lesions are in a location that are likely to be affected by respiratory motion (eg. hepatic, peritoneum, mesentery, serosal) then lesions larger than 3 cm would be desirable, if at all possible. DIFFUSE ILL-DEFINED PERITONEAL IMPLANTS 1 cm PERITONEAL IMPLANTS

This lesion is ill-defined and in a location subject to respiratory motion

These nodules are well defined, but small and in a location subject to respiratory motion.

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PERIHEPATIC CYSTIC/MUCINOUS LESION or LOCULATED ASCITES

Well defined hepatic or perihepatic lesion, of a satisfactory size, but its noncontrast density suggests that it might be a cystic or mucinous lesion, which would not take up IV contrast.

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Site Technologist Tips ACRIN 6695

• Scanner to be used must have been prequalified by ACRIN per 6695 protocol. If there is a tube change the scanner must be requalified before scanning another ACRIN 6695 patient.

• Scan patient on the same scanner that was qualified by ACRIN. Also the patient must be scanned on the same scanner for all follow up scans that was qualified by ACRIN.

• Start or Use appropriate IV setup to attain fastest injection rate per protocol.

• Check protocol parameters on scanner are per 6695 protocol.

• Use DFOV appropriate for patient body habitus then follow up scan must have the exact DFOV for all subsequent time points.

• Perform a screen save or screen capture of the Target Lesion as well as the Dose Report/Patient Protocol and submit to ACRIN per protocol.

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ACRIN 6695 – Appendix I: Creating, Anonymizing, and Importing Screen Captures

A. Pull up the desired screen/image to be captured B. Click PRINT SCREEN to take a snapshot making this a screen capture of

the image

C. Now open Paint program.

D. Click Edit and Paste

E. The saved snapshot will now appear in the Paint program

F. Crop out or paint over any unwanted patient identifiers (Specifically, subject name, institution MR number and date of birth are to be removed) so the content of the screen capture is the only viewable object on the screen.

G. The snapshot has now been anonymized, click file – save as

H. You may now name the screen capture and save in .jpeg format - (you can

save it temporarily to your desktop to be uploaded to TRIAD)

I. Repeat this process for each individual screen capture you wish to submit

J. Now the newly anonymized screen captures are ready to be imported to TRIAD as an attachment in order to be maintained in the study archive

Please contact TRIAD Support with any questions regarding importation of

images or file attachments: Phone: 215-940-8820

Email: triad-support@acr.org