The Cancer Imaging Program (CIP) supports projects in regulatory affairs, medical imaging agent availability, and imaging informatics under the overall mission of supporting discovery and development of cancer treatment modalities utilizing imaging platforms. The regulatory support that CMRP provides to the Cancer Imaging Program has enabled wider availability of investigational agents for exploratory clinical trials -- by contract, in the research community, and within the Joint Early Phase Therapeutics Development Program (JDC) and the Imaging Drug Group (IDG). The program supports INDs for agents being evaluated in brain tumors, metastatic prostate cancer, cervical cancer, metastatic breast cancer and lung cancer. These medical imaging drugs include Position Emission Tomography (PET), single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MR) specific contrast agents. Additionally, the Regulatory Affairs Director collaborates with other programs within NCI, with other groups within NIH at the Clinical Center and Frederick, and with scientific societies and FDA to support the CIP program goals of wider use of medical imaging in diagnosis, stratification of patients to treatments, response to therapy monitoring, therapeutic drug development and medical decision making. These activities include web, meeting, and workshop outreach; advising interested parties on the requirements of clinical research with IND agents, providing letters of authorization to CIP INDs to independent researchers and pharmaceutical companies that wish to file their own INDs for research, encouraging the small radiopharmaceutical manufacturers to file the needed Drug Master Files to permit wider use of short half-life agents that have no IP associated with them. An important aspect of the program is its application to systems biology and investigation of the basic biological mechanisms of cancer genesis and growth. The effort is translations, with bench to bedside and back a key aspect of the program. The IT management support is a major contributor to initiatives across NCI in support of its imaging informatics plan. An IT manager collaborates with multiple NCI-wide committees and oversees the major initiatives in imaging informatics. This work has proven important in the NCI's development of an infrastructure that supports imaging informatics and is aimed at higher-level compatibility with CBIIT's caBIG (Cancer Biomedical Informatics Grid) and other NIH Roadmap Initiatives. The National Cancer Imaging Archive (NCIA) contains databases of medical images that can now be used by outside entities to develop and test computer aided diagnostic tools for lung cancer, virtual colonography, and brain tumors.
