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Clinical trials with ico metrix

Imaging biomarkers in Clinical trials

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Page 1: Imaging biomarkers in Clinical trials

Clinical trialswith icometrix!

Page 2: Imaging biomarkers in Clinical trials

  Quantitative MRI biomarkers for you ?  About icometrix  Experience  Future

The use of high quality MRI data and quantitative MRI biomarkers is recommended in the latest guidelines of the European Medicine Agency (EMA) on clinical investigation of medicinal products for treatment of dementia, multiple sclerosis and other neurological disorders.www.ema.europa.eu

!!

Page 3: Imaging biomarkers in Clinical trials

HISTORY MEASURING BLOOD GLUCOSE

Clarke et al. 2012

Sight, touch, smell & taste

Copper reagent tablet

First glucose meter for quantification

Standardized glucose measures

Reduced observer-dependency & measurement error!

Better patient monitoring & treatment decisions!

Improved outcome for patients!

Standardization!

Page 4: Imaging biomarkers in Clinical trials

HISTORY OF MRI MEASUREMENTS

“EYE-BALLING” à STANDARDIZED MEASUREMENTS

Reduced observer-dependency & measurement error!

Better patient monitoring & treatment decisions!

Improved outcome for patients!

Standardization!

Page 5: Imaging biomarkers in Clinical trials

BRA IN IMAG ING B IOMARKERSAlzheimer’s Disease

Parkinson’s DiseaseHuntington’s Disease

Amyotrophic lateral sclerosis

StrokeTraumatic brain injury

EpilepsyMigraine

AutismAnxiety Disorders

Multiple SclerosisSleep Disorders

Major Depressive Disorder Bipolar Disorders

Schizophrenia

* Definition by icometrix!

Brain imaging biomarkers are features that can be detected on a medical brain scan (visually or by computerized analyses). For patients with a neurological disorder, imaging biomarkers provide neurologists & radiologists with key information on how the disease is progressing in their brain. Imaging biomarkers can give an indication of how well treatment is working. *

Page 6: Imaging biomarkers in Clinical trials

MRI & CT!

Imaging biomarkers for anatomical MRI or CT images as well as for functional, diffusion and perfusion MR images.

Guidance for imaging protocol!Imaging data managementQuality control!

Close collaboration for result reporting & statistics!

icometrix quantitative MRI biomarkers

Page 7: Imaging biomarkers in Clinical trials

To measure is to knowAutomated quantification of imaging biomarkers provides fast and objective answers.

From one to many!

Biomarkers for clinical practice:•  low measurement error •  high accuracy

Trial: maximize the power!

Advanced image analysis!

•  Anatomical•  Functional •  Diffusion •  Perfusion•  Spectroscopy

icometrix quantitative MRI biomarkers

Page 8: Imaging biomarkers in Clinical trials

  Quantitative MRI biomarkers for you?

  About icometrix

  Experience  Future

!!

Page 9: Imaging biomarkers in Clinical trials

Leuven Belgium !Boston USA !

Dirk Loeckx & Wim Van Hecke !

Quantitative image analysis !for clinical practice & clinical trials !

Founded in 2011 by

Page 10: Imaging biomarkers in Clinical trials

Active in !

ISO9001, ISO13485 (Medical Devices) & ISO27001 (Information Security)

> 30 countries> 300 centers!

Leuven Belgium !Boston USA !

HIPAA compliant !

Grown to an established organization

Page 11: Imaging biomarkers in Clinical trials

MSmetrix � icobrain !CE approved � FDA cleared

Reliably track brain v o l u m e l o s s!

Closely monitor new & enlarging FLAIR w h i t e m a t t e r h y p e r i n t e n s i t i e s!

Brain MRI biomarkers made easy to monitor neurological disorders !

Time

V O L U M E L O S S!

B R A I N

Time

I N F L A M M A T I O N !

Page 12: Imaging biomarkers in Clinical trials

MSmetrix � icobrain !CE approved � FDA cleared

Brain MRI biomarkers made easy to monitor neurological disorders !

Page 13: Imaging biomarkers in Clinical trials

  Quantitative MRI biomarkers  About icometrix

  Experience  Future

!!Dr. Max Wintermark, M.D., Professor of Radiology & Chief of Neuroradiology at the Stanford University Medical Center.

MRI biomarkers are becoming of vital importance in the clinical care path for various pathologies including neurological disorders such as multiple sclerosis, traumatic brain injury and stroke. It is of paramount importance that the biomarker measurements are extremely reproducible & sensitive enough to detect relevant clinical changes.

Page 14: Imaging biomarkers in Clinical trials

Collaborations Imaging

Research institutes & hospitals worldwide

Clinical trials

Phase I, II, III, IV

Multiple Sclerosis,Trauma, stroke,

Epilepsy, Parkinson’s disease, Alzheimer’s disease

Cloud service

Fast & secure processing of large datasetsRegistries

Segmentationmulti-modal registration,

diffusion analysis, population studies & stratification, MR spectroscopy, etc.

EXPERIENCE in clinical trials & clinical practice

Easy data transfer & data

management

Top pharma

Page 15: Imaging biomarkers in Clinical trials

Retrospective clinical trial data!More significant results & better patient selection

MS clinical trials!Cost-effective, lower sample size needed & better

patient selection

More CNS trials!Cost-effective, lower sample size needed & better

patient selection

Page 16: Imaging biomarkers in Clinical trials

  Quantitative MRI biomarkers  About icometrix  Experience

  Future

To measure is to know. If you cannot measure it, you cannot improve it. !Lord KelvinScots-Irish mathematical physicist & engineer (1824 – 1907)

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Page 17: Imaging biomarkers in Clinical trials

IMPACT FOR P A T I E N T S

Monitoring therapy response and disease progressionPatient selection for optimal treatment and

treatment changePatient selection for clinical trials

Improved outcomes of clinical trials

New era of personalized medicineNew era of digital health

New era of patient empowermentIncreased need for objective biomarkers

Increased costs to bring drugs on the market

HEALTHCARE(R)EVOLUTION

Non-invasiveAutomated (thus cost-effective)

Reliable markers of disease progressionReduce sample size of clinical trials

I M A G I N GBIOMARKERS

Page 18: Imaging biomarkers in Clinical trials

icometrix!

Real world data

Neurological disorders!

Therapy & monitoring go hand in hand

Help patients!

Incorporate imaging biomarkers

Shift to digital health

Improve cost-efficiency of clinical trials

Next step in Radiology

Right drug / medical device !Right patient !Right time ! You?!

Page 19: Imaging biomarkers in Clinical trials

icometrix!

[email protected]

www.icometrix.com