Imaging_as_Biomarkers.ppt
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Transcript Imaging_as_Biomarkers.ppt
Imaging as a biomarker:
standards for change
measurements in therapy
NIST, Gaithersburg, MD
Workshop « Imaging as Biomarker »
General issue: Imaging use for Clinical trials
Organized by NIST
Supported by:
Sponsoring organization: NIH, NCI (Larry Clarke)
FDA
Pharmaceutical industry: PhRMA, big labs
Normalization structures: NIST, NEMA
Professional societies: RSNA, AAPM, SNM,
ISMRM, SPIE
Vendors: Siemens, GE, Philips
The issues (1/2)
Use of imaging to evaluate new treatment
efficiency:
Not only a subjective reading of images
But, more and more objective measurements with
“quantitative” methods
Examples : Alzheimer desease, lung cancer,
arthrosis…
Low efficiency statement of clinical trials
Longs, expensives, and often… no positive result!
…
The issues (2/2)
Main reasons:
Too often, mediocre quality of image data
No quantitative
Reproducibility issues (intra system and inter systems)
Acquisition protocols non respected → lot of cases are non usable
Data processing differs between different site (→ “site” effect)
Too subjective
Not enough automated
Insufficient quality of clinical data associated
“Local” semantic for clinical information
Resulting bias amplify intrinsic variability of the phenomena
→ increase of the necessary number of cases
Data management cost
Because support tools needs to be rebuild case by case
Data cannot be re-used
Despite the politic of sponsoring organizations (dissemination plan)
No sharing infrastructure
Solution components,
standard based (1/2)
Standard phantoms to calibrate imaging systems
Standard study protocols
To be really identical between machines (patient preparation,
image acquisition, pre-processing and applied corrections,
reconstruction…)
Standard procedures (guidelines) to manage clinical
trials
good comprehension of protocols, physician and
technologists education, quality assurance
Meta data and clinical data standardization
Need the use of normalized terminologies, ontologies…
Solution components,
standard based (2/2)
Management tools adapted to the data and processing
management
Scientific calculation
Step sequencing (including quality assurance)
Providing the required traceability
Compatibility issues with current PACS (regarding image
management)
Reference implementation (open source shared tools)
Standard processing tools (that can be shared)
Open source
Plug-in or services remotely executable
Standard data
Anatomical atlases
Reference data (e.g. healthy populations )
Needs for the future
Medical
No more and less than tomorrow treatments for numerous
pathologies
Vendors
Pharmaceutical industry, decrease of validation costs for
new medication
Imaging systems industry
New generations of systems. Economical model.
Sharing / interoperability of processing tools
Scientific
Validation of processing and image quantification tools
Diffusion and re-use of tools
What happened since the
NIST workshop ?
The Gil Jost (RSNA), Larry Clarke (NCI)
and Michael Vannier (University of
Chicago) propositions were well
received in France and in Europe.
SFR and ESR decided to join RSNA
and NCI in an international initiative on
biomarkers.
RSNA meeting
At RSNA meeting, Guy Frija (ESR) and Philippe
Grenier (SFR) met Gil Jost (RSNA) and FDA
representatives to discuss on this topic.
FDA representatives:
Said that they will greatly appreciate if Europe join the
project,
Asked SFR and ESR to investigate to find European
partners.
RSNA, SFR and ESR agreed to say that they can
be partners of the initiative for all imaging issues,
but not leaders. They will transmit users needs on
this topic to DICOM and imaging vendors.
Recent developments
In France:
SFR have contacts with AFSAPS (FDA like French
Agency),
Sanofi-Aventis (pharmaceutical lab) is interested.
In Europe:
EMEA (European MEdicine Agency) is interested,
EFPIA (European Federation of Pharmaceutical
Industries and Associations) will be contacted
soon,
Novartis (pharmaceutical lab) will probably be
interested: it is searching for a radiologist to
manage a biomarker department.