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Clinical trials
with 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
!!
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!
BRAIN IMAGING BIOMARKERS
Alzheimer’s Disease
Parkinson’s Disease
Huntington’s Disease
Amyotrophic lateral sclerosis
Stroke
Traumatic brain injury
Epilepsy
Migraine
Autism
Anxiety Disorders
Multiple Sclerosis
Sleep 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 management
Quality control!
Close collaboration for result reporting &
statistics!
icometrix quantitative MRI biomarkers
To measure is to know
Automated 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
!!
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 Ÿ icobrain!
CE approved Ÿ 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 Ÿ icobrain!
CE approved Ÿ 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 datasets
Registries
Segmentation
multi-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 Kelvin
Scots-Irish mathematical physicist
& engineer (1824 – 1907)
!!
IMPACT FOR
P A T I E N T S
Monitoring therapy response and disease progression
Patient selection for optimal treatment and
treatment change
Patient selection for clinical trials
Improved outcomes of clinical trials
New era of personalized medicine
New era of digital health
New era of patient empowerment
Increased need for objective biomarkers
Increased costs to bring drugs on the market
HEALTHCARE
(R)EVOLUTION
Non-invasive
Automated (thus cost-effective)
Reliable markers of disease progression
Reduce sample size of clinical trials
I M A G I N G
BIOMARKERS
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?!
icometrix!
info@icometrix.com
or
www.icometrix.com

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Imaging biomarkers in Clinical trials

  • 2.  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 !!
  • 3. 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!
  • 4. HISTORY OF MRI MEASUREMENTS “EYE-BALLING” à STANDARDIZED MEASUREMENTS Reduced observer-dependency & measurement error! Better patient monitoring & treatment decisions! Improved outcome for patients! Standardization!
  • 5. BRAIN IMAGING BIOMARKERS Alzheimer’s Disease Parkinson’s Disease Huntington’s Disease Amyotrophic lateral sclerosis Stroke Traumatic brain injury Epilepsy Migraine Autism Anxiety Disorders Multiple Sclerosis Sleep 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. *
  • 6. 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 management Quality control! Close collaboration for result reporting & statistics! icometrix quantitative MRI biomarkers
  • 7. To measure is to know Automated 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
  • 8.   Quantitative MRI biomarkers for you?  About icometrix   Experience   Future !!
  • 9. Leuven Belgium! Boston USA! Dirk Loeckx & Wim Van Hecke ! Quantitative image analysis ! for clinical practice & clinical trials! Founded in 2011 by
  • 10. Active in! ISO9001, ISO13485 (Medical Devices) & ISO27001 (Information Security) > 30 countries > 300 centers! Leuven Belgium! Boston USA! HIPAA compliant! Grown to an established organization
  • 11. MSmetrix Ÿ icobrain! CE approved Ÿ 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!
  • 12. MSmetrix Ÿ icobrain! CE approved Ÿ FDA cleared Brain MRI biomarkers made easy to monitor neurological disorders !
  • 13.   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.
  • 14. 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 datasets Registries Segmentation multi-modal registration, diffusion analysis, population studies & stratification, MR spectroscopy, etc. EXPERIENCE in clinical trials & clinical practice Easy data transfer & data management Top pharma
  • 15. 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
  • 16.   Quantitative MRI biomarkers  About icometrix   Experience   Future To measure is to know. If you cannot measure it, you cannot improve it. ! Lord Kelvin Scots-Irish mathematical physicist & engineer (1824 – 1907) !!
  • 17. IMPACT FOR P A T I E N T S Monitoring therapy response and disease progression Patient selection for optimal treatment and treatment change Patient selection for clinical trials Improved outcomes of clinical trials New era of personalized medicine New era of digital health New era of patient empowerment Increased need for objective biomarkers Increased costs to bring drugs on the market HEALTHCARE (R)EVOLUTION Non-invasive Automated (thus cost-effective) Reliable markers of disease progression Reduce sample size of clinical trials I M A G I N G BIOMARKERS
  • 18. 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?!