NCI/NIST Perspective on IGI Research and Related Standards Laurence P. Clarke PhD, FAAPM; FISMRM NCI, DCTD, Cancer Imaging Program Detail (NIBIB) Guest Scientist ( NIST) “NCI GT” and NA-MIC Workshop Oct 19 th 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 5 th 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:

NTROI: Techniques and Organ Systems Team 1: UC Irvine--Breast Cancer Diffuse optical imaging and spectroscopy Team 2: Boston University--Esophageal Cancer Elastic scattering spectroscopy and optical pharmacokinetics" (fast UV through IR analytical in vivo spectrophotometry) Team 3: Univ. of Pennsylvania--Animal models of GI cancer In vivo bioluminescence imaging and optical measures of metabolic activity Team 4: Stanford University--GI Cancers Fiber-based confocal microscopy for in vivo measures of histopathology Optical “biopsy” EGFR

Open Source Acquisition and Analysis Platform Cross Validation Studies Clinical Decision Tools Clinical Trials 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 Prototypes Professional, product grade software and algorithm development Distributed Enterprise IT Integration Collaborative Data Management System Rapid Application Development System Plug-in Arch. & Standard Objectives Drive rapid convergence of scientific consensus and validation thru 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 Growth Shrinkage Image registration; pixel intensity/density change, volume or shape.. … NCI NIBIB: 2 Fellows (FDA) NIST Scientists: 2 FTE’s RIDER Academic Scientists Industry 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 1 st 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: : NCI FDA IOTF: OBQI: FDA new pathways report: Drug Response: RIDER Database resource for software evaluation: NIST Workshop: NIH Road Map: