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

2. 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)

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

5. 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

6. 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”

7. 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.

8. 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

9. Inter-agency activities Inter-agency Forum Inter-agency Council NCI-FDA Task Force NCI-CMS Task Force

10. National Institute of Biomedical Imaging and Bioengineering (NIBIB) Emphasis on basic or generic technologies Evaluation or validation of physical performance Training grants

11. Imaging as a Biomarker Issues: Reproducibility Correlation with biological parameter Reference standard

12. Imaging as a Biomarker Initial focus for NCI: FDG-PET DCE-MRI Near-term focus FLT-PET (IND done; Phase 1 in progress). MRS

13. 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

15. 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

16. 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)

17. 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.orgwww.rsna.org (Research programs)

18. Cancer Imaging Program imaging.cancer.gov cip.cancer.gov 301 496 9531

19. CIP Vision Statement: Cancer Imaging – Visualize the problem and direct the solution. Tel: 301 496 9531