imaging biomarkers in clinical trials
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Clinical trialswith icometrix!
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
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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!
HISTORY OF MRI MEASUREMENTS
“EYE-BALLING” à STANDARDIZED MEASUREMENTS
Reduced observer-dependency & measurement error!
Better patient monitoring & treatment decisions!
Improved outcome for patients!
Standardization!
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. *
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
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
Quantitative MRI biomarkers for you?
About icometrix
Experience Future
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Leuven Belgium !Boston USA !
Dirk Loeckx & Wim Van Hecke !
Quantitative image analysis !for clinical practice & clinical trials !
Founded in 2011 by
Active in !
ISO9001, ISO13485 (Medical Devices) & ISO27001 (Information Security)
> 30 countries> 300 centers!
Leuven Belgium !Boston USA !
HIPAA compliant !
Grown to an established organization
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 !
MSmetrix � icobrain !CE approved � FDA cleared
Brain MRI biomarkers made easy to monitor neurological disorders !
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.
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
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
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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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
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?!