This is a single arm prospective trial that evaluates the ability of a novel imaging agent gallium-68 labelled (68Ga-) FAP-2286 (68Ga-FAP-2286) to detect metastatic cancer in participants with solid tumors using 68Ga-FAP-2286 tracer. FAP-2286 is a peptidomimetic molecule that that binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on cancer-associated fibroblasts, and has been shown to be present on a number of solid tumors.
Initially the investigator(s) will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer. STUDY AIMS 1. determine the dosimetry for gallium-68 labelled (68Ga-) FAP-2286, 2. evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286, and 3. evaluate the ability of FAP-2286 to detect metastatic disease. PRIMARY OBJECTIVES 1. All cohorts: Safety of 68Ga-FAP-2286 2. Cohort 1: determine the organ dosimetry of 68Ga-FAP-2286 3. Cohort 2: determine the feasibility of detecting tumor uptake using 68Ga-FAP-2286 4. Cohort 3: determine the feasibility of detecting metastatic disease using 68Ga-FAP-2286 EXPLORATORY OBJECTIVES 1. Correlation of 68Ga-FAP-2286 uptake with FAP expression determined by immunohistochemistry. 2. Compare 68Ga-FAP-2286 scan results to archival Fluorodeoxyglucose (FDG)-PET images. 3. Compare biodistribution of 68Ga-FAP-2286 in normal organs and blood pool based on renal function. 4. Determine impact of administered dose of 68Ga-FAP-2286 on image quality. A repeat 68Ga-FAP-2286 PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Patients will be followed for up to 3 days after the injection of 68Ga-FAP-2286 for evaluation of adverse events.