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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