The Truman VA Hospital is requesting funds to purchase a collection of 12 unique instruments to be employed collectively as an integrated system for establishing the Truman VA Clinical Research Radiopharmacy. The Clinical Research Radiopharmacy will have the capacity to synthesize, perform quality control, and dispense novel gallium-68 (68Ga) labeled radiopharmaceuticals. These novel 68Ga labeled radiopharmaceuticals will be used in conducting clinical molecular imaging trials (using clinical PET/CT imaging) for assessing the unique capabilities of 68Ga-radiopharmaceuticals to improve early detection, monitor disease progression/therapeutic efficacy, and stage disease for veterans with cancer. The 68Ga clinical imaging products that we are proposing to create, using the resources of the Clinical Research Radiopharmacy, will be generated from a collection of VA Merit and extramurally funded research to address clinical diagnostic imaging needs in the specific areas of metastatic prostate cancer, neuroendocrine tumors, and metastatic melanoma. The performance of clinical imaging research requires a physician sponsored IND application be approved by the FDA, prior to conducting any clinical research involving veterans. To achieve these goals we have assembled a team comprised of a radiopharmaceutical chemist, clinical pharmacist, licensed radiopharmacist, clinical nuclear medicine physician, and a certified nuclear medicine technologist, in order to produce, dispense, and utilize clinical grade PET research radiopharmaceuticals that are compliant with current FDA, NRC, NHPP, and USP regulations and guidelines.

Establishing the Truman VA Clinical Research Radiopharmacy directly addresses two of our primary mission goals to 1) advance knowledge to improve Veterans' health (by locally establishing translational research oncology drug development capacity) and 2) apply state-of- the-art advances (in clinical molecular imaging) to assure that Veterans receive an effective precision medicine approach to individualized care. At the local level, the resources of the Clinical Research Radiopharmacy will support an ongoing program of VA Merit funded PI's developing new cancer imaging agents while at the national VA level, dissemination of drug synthesis SOP's and techniques will facilitate widespread multi-center trial availability to a significant portion of our veteran population.