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