ShEEP-IC: Truman VA Clinical Research Radiopharmacy

Harry S. Truman Memorial Va Hospital, Columbia MO

Investigators

Abstract

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.