Radiopharmaceuticals can diagnose and treat cancer. The recent explosion in development of monoclonal antibodies specifically directed at individual cancers has greatly broadened the horizons of radiopharmaceuticals. Yet we have only begun to explore these clinical uses of radiopharmaceuticals. A major reason that radiolabeled compounds have only slowly reached clinical utility is that there are multiple sequential steps in their development with each step requiring the expertise of specialized scientists. This process is expensive and difficult to coordinate. Few academic organizations have the broad-ranging expertise to undertake such ventures, and pharmaceutical companies may see but a limited market for a single radiopharmaceutical directed at a particular cancer. Indeed, such radiopharmaceuticals become """"""""orphan drugs"""""""", agents of great clinical value but too costly to attract a """"""""parent"""""""". We propose a program project that will enable the orderly development of useful radiolabeled compounds from concept and production through clinical trials in the diagnosis and treatment of cancers. The program project will organize scientists into cores where collaberations will ensure that a promising agent will efficiently proceed from synthesis to radiopharmaceutical to clinical evaluation. The program project will support a radiopharmaceutical development core facility composed of 1) production and labeling; 2) pre-clinical evaluation; 3) dosimetry; 4) clinical evaluation; and 5) administrative cores. Each core will consist of scientists with sufficient time and knowledge to carry out specialized yet coordinated experiments, and each core will have the space, equipment and funds to support the efforts of these scientists. Their efforts will be coordinated by the principal investigator and an administrative committee to ensure efficacy in the program project grant. Interdisciplinary, synergistic sub-projects supported by the facility include the evaluation of radiopharmaceuticals developed from: monoclonal antibodies for the diagnosis and possible therapy of: lymphoma, bladder and breast cancers as well as metaiodobenzylguanidine an analog of norepinephrine to diagnose and treat neuroblastomas. These radiopharmaceuticals will be better evaluated in animals through the development of a high- resolution small animal tomographic imaging device. Through this series of mutually reinforcing projects supported by the core labs, the end result should be improved diagnosis and treatment of cancer.
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