NCI/NIST Perspective on IGI Research and Related Standards
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Transcript of NCI/NIST Perspective on IGI Research and Related Standards
NCI/NIST Perspective on IGI Research and Related
Standards
Laurence P. Clarke PhD, FAAPM; FISMRM
NCI, DCTD, Cancer Imaging ProgramDetail (NIBIB)
Guest Scientist ( NIST)“NCI GT” and NA-MIC Workshop
Oct 19th st 2006
NCI Initiatives: Imaging Standards
• NTROI: Systems approach to validating optical imaging platforms and related standards
• LIDC-RIDER: Database resource for standardized benchmarking of software tools.
• NCI caBIG: Imaging workspace and workstation: focus open source validation tools.
• Trans Agency: Public Private Partnerships– Oncology Biomarker Qualification Initiative (OBQI)– Biomarker Consortium: Pharma Oct 5th 2006– NIST Trans Agency Workshop: Imaging standards.
• NEW PAR: RO1: – Academic-Industry Partnerships
• Bridge disciplines: Oversight by a steering committee: Funded activity.– Connect instrumentation development teams to
biologists, chemists, and clinical teams– Sharing of optical and molecular imaging probes and
cross validation studies– Sharing common IT and open source tools– Engage scientists with different federal agencies and
industry: FDA, NIST, NIH and over 30 cooperate partners, to develop broad consensus on validation methods that may lead to imaging standards.
Build an international research network to develop a systems approach for molecular imaging for drug discovery, drug response and IG delivery
NTROI Objectives: U54: 2003-08
NTROI: Techniques and Organ Systems
• Team 1: UC Irvine--Breast CancerDiffuse optical imaging and spectroscopy
• Team 2: Boston University--Esophageal CancerElastic scattering spectroscopy and optical
pharmacokinetics" (fast UV through IR analytical in vivo spectrophotometry)
• Team 3: Univ. of Pennsylvania--Animal models of GI cancerIn vivo bioluminescence imaging and optical
measures of metabolic activity
• Team 4: Stanford University--GI CancersFiber-based confocal microscopy for in vivo measures of histopathology
Optical “biopsy”EGFR
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Open Source Acquisition and Analysis Platform
Cross Validation StudiesClinical Decision Tools
ClinicalTrials
Stand-alone Tools
for “offline” Fusion
Research
Algorithms & Software
Libraries for
Registration of Optical
with MR & Xray, &
Analysis
Improve Optical Tomography & Enhance Clinical Utility of Optical Data
Clinical PrototypesProfessional, product grade software and algorithm
developmentDistributed Enterprise IT
Integration
Collaborative
Data Management
System
Rapid Application Development System
Plug-in Arch. & Standard
Objectives
Drive rapid convergence of scientific consensus and validationthru shared databases and software
Multi-vendor compatible IT for efficient clinical trials, and rapid translation to products from multiple vendors
Deliverables
Technologies
Reference Image Database for Drug Response (RIDER)
Resource: Benchmarking Performance of Change Analysis
Software:
Imagery + mark up “truth”
Corpus(Large)
Development Set
Sequestered for Testing
Consensus on methods and measure sources of uncertainty .
Change Analysis Tools
Standardized Performance Analysis
(Computer ROC)
No change
GrowthShrinkage
Image registration; pixel intensity/density change, volume or shape.. …
NCI NIBIB: 2 Fellows (FDA)NIST Scientists: 2 FTE’sRIDER Academic ScientistsIndustry Scientists
One potential method to engage
stakeholders for IGI standards
NIST Workshop Report• The NIST meeting was a
stakeholders meeting attended by 260 scientists:– Imaging and Pharma Companies, – CRO’s and Trade Organizations
• (NEMA, PhRMA Consortium),
– RSNA, ACR, AAPM, SNM, ISMRM– Federal Government
• (NIH: NCI, NIBIB, NIA, NIAMS, NIGM, NCRR)
•FDA (CDRH, CDER)•NIST (CSTL, EEEL, PL, MSEL, MEL ).
NIST Workshop Report• There was a very strong
agreement across all stakeholders that:– uncertainty in data collection and
analysis across single and different imaging platforms was an important problem for quantitative measurements as applied to drug trials
– i.e.., in addition to the biological uncertainty, which was not a focus of this workshop.
NIST Workshop Report• There was a strong interest by all
stakeholders to address these measurement problems and proposed several short, mid- and long-term recommendations to implement standards:– Several academic societies are willing to
both support and collaborate with Gov. agencies , leveraging the volunteer time of their members.
– NEMA expressed interest in representing the imaging industry in any interagency or NIST effort, and partner with PHRMA
– RSNA expressed an interest in helping to facilitate follow up stakeholders meetings, IHE was posed as an example, that was industry lead.
Examples of Areas Mentioned• Define the physical performance of different
imaging platforms required to measure change analysis.
• Design phantoms that may better characterize the time related physical performance of imaging systems, and the performance for specific functional and molecular based measurements.
• Develop and share open source tools to analyze phantom or simulated data.
• Develop and share open source tools for validation and image mark up of clinical data, including statistical methods.
• Develop public resources to help optimize and validate imaging methods prior to their implementation in drug trials.
• Develop scalable resources to archive de-identified image and meta data, in collaboration with industry.
NCI PAR: Academic-Industry Partnerships
• R01: Goal: Accelerate translational research, encourage delivery of technologies and methods for multi site clinical trials. April 1st 2007.
• Partnerships Required or encouraged.– Industry Device and/ or Pharma required.– Collaboration with NIH intramural, FDA, NIST scientists,
through the use of visiting scientists– Multi PI’s and linked R01’s permitted– Collaboration with other cooperative agreements
• Research emphasis: – Imaging Platforms: Human and Pre Clinical– Validation of multi-modality imaging platforms– Open source architecture and software tools– Development of public resource for Q/C, validation of
imaging methods- software tools
URL’s for reference• NCI CIP Program: : http://imaging.cancer.gov/
• NCI FDA IOTF: http://iotftraining.nci.nih.gov/
• OBQI: http://ww.cancer.gov/newscenter/pressreleases/OBQI
• FDA new pathways report: Drug Response: http://www.fda.gov/oc/initiatives/criticalpath/
• RIDER Database resource for software evaluation:• http://imaging.nci.nih.gov/i3/
• NIST Workshop: http://usms.nist.gov/workshops/bioimaging.htm
• NIH Road Map: http://nihroadmap.nih.gov/bioinformatics/grants.asp