Instant Kit Synthesis of 62Cu Radiopharmaceuticals

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DESCRIPTION (provided by applicant): Positron Emission Tomography (PET) is a rapidly emerging non-invasive imaging technique with the exceptional ability to provide quantitative functional information. Unfortunately, this modality is currently limited to a single approved radiopharmaceutical agent, 18F-FDG, which measures tumor metabolism. The potential of PET in oncology can be advanced substantially by development of PET tracers that can assess other useful clinical parameters, such as the quantitative measurement of tumor perfusion and hypoxia. Such information is extremely useful for diagnosis and staging of cancer. We propose to develop a micro 62Znfl2Cu generator to produce the 9.7 minute 62Cu PET tracer at very high isotonic concentration and further to develop kit formulations to provide instant synthesis of 62 Cu-bis(thiosemicarbazone) compounds. Phase I will concentrate on demonstrating the feasibility of the combined microgenerator and instant kits for the two perfusion tracers approximately Cu-PTSM and x2CU-ETS, and the hypoxia tracer 62 Cu-ATSM. In Phase II, the microgenerator and kit formulations will be fully developed for human use, INDs will be submitted to the FDA for the three compounds, and finally, limited clinical feasibility studies focusing on serial perfusion and hypoxia imaging completed in a brief imaging session will be performed. The resulting perfusion normalized hypoxia map is expected to produce a highly superior measure of regional tumor hypoxia and thus superior information to guide treatment. The distributable generator produced tracers, together with the widely expanding availability of PET, can have far-reaching benefits in cancer patient treatment and management.