NFBIO: Update on NCI Imaging Activities Daniel C. Sullivan, M.D. Cancer Imaging Program, DCTD, NCI

NFBIO:Update on NCI

Imaging Activities

Daniel C. Sullivan, M.D.Cancer Imaging Program, DCTD,

NCI

Basic/Translational Research

In vivo Cellular and Molecular Imaging Centers (ICMIC)Small Animal Imaging Resource Programs (SAIRP)Network for Translational Research in Optical Imaging (NTROI)Radionuclide Resource (Wash Univ)

Technology Development

PA’s for Technology Development, Bioengineering Research Grants (BRG), and Bioengineering Research Partnerships (BRP)SBIR grants

Comments on Tech Development:

SBIR program for small businessesLarge companies are somewhat at a disadvantage in competition with academician “grant-writers”; and Large companies may be at a disadvantage in Review (which is predominantly academicians)Nevertheless, large companies do succeed in winning grants

NCI Assistance for Imaging Agent Development

CIP uses contract vendors or sites to assist developers Development of Contrast Imaging

Drugs and Enhancers (DCIDE) – preclinical development

Phase 1 and 2 clinical trial contract sites (MGH, Univ Wash, JHU, VCU).

CIP:“Venture capitalists for the public good”

DCIDE; Phase 1,2 TrialsCTA with AMI; IND’s for Combidex, ferrumoxytol; Trials active.CTA with GE Healthcare; IND for FLT filed. Phase 1 trial in development.3 “boxes” purchased and placed at contract sites for SOP’s of 3 other radiopharmaceuticals.

Clinical Trials

R21 PA for “Quick Trials” $250K/yr x 2 yrs

ACRIN (Cooperative Group for imaging trials) www.acrin.org

CTEP Cooperative GroupsR01

Inter-agency activities

Inter-agency ForumInter-agency CouncilNCI-FDA Task ForceNCI-CMS Task Force

National Institute of Biomedical Imaging and Bioengineering

(NIBIB)

Emphasis on basic or generic technologiesEvaluation or validation of physical performanceTraining grants

Imaging as a Biomarker

Issues: Reproducibility Correlation with biological

parameter Reference standard

Imaging as a Biomarker

Initial focus for NCI: FDG-PET DCE-MRI

Near-term focus FLT-PET (IND done; Phase 1 in

progress). MRS

Current ActivitiesCoordinated approach to FDG-PET correlative studies in NCI Cooperative Group therapy trials.Infrastructure to facilitate central archiving and review of images from clinical trials Collaboration with RSNA MIRC

Relevant Workshops

Imaging and Oncology: How to Build a Successful Partnership. October 14-15, 2004MR in Clinical Assessment of Anti-Tumor Therapies. November 21-22, 2004The Role of FDG-PET in the Evaluation of Therapeutic Response in Cancer. January 9-10, 2005

New Program: IRAT’s

Imaging Response Assessment Teams Cancer Center Supplements(~$250 K/yr/site) Imaging MD and PhD involvement into

protocol development and data evaluation

Collaboration with the American Association of Cancer Institutes (AACI) and the American Cancer Society (ACS)

New RSNA Training Course

Clinical Trial Methodology CourseJanuary 7 – 13, 2006, Phoenix AZCompetitive selection processEach student will write a clinical trial protocol during the course.www.rsna.org (Research programs)

Cancer Imaging Program

imaging.cancer.gov

cip.cancer.gov

301 496 9531

CIP Vision Statement:

Cancer Imaging – Visualize the problem

and direct the solution.

Tel: 301 496 9531