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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)
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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 businesses • Large 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 Trials • CTA 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 Groups • R01
Inter-agency activities • Inter-agency Forum • Inter-agency Council • NCI-FDA Task Force • NCI-CMS Task Force
National Institute of Biomedical Imaging and Bioengineering (NIBIB) • Emphasis on basic or generic technologies • Evaluation or validation of physical performance • Training 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 Activities • Coordinated 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, 2004 • MR in Clinical Assessment of Anti-Tumor Therapies. November 21-22, 2004 • The 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 Course • January 7 – 13, 2006, Phoenix AZ • Competitive selection process • Each 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