Thomas Hope
This is a multi-arm prospective trial that evaluates the ability of a novel imaging radiolabeled agents to detect metastatic cancer in participants with solid tumors using a gallium 68 (68Ga-) or copper 64 (64Cu-) 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-) and 64Cu- FAP-2286. 2. Evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286. 3. Evaluate the ability of FAP-2286 to detect metastatic disease. PRIMARY OBJECTIVES 1. All cohorts: Safety of 68Ga- and 64Cu-FAP-2286. 2. Cohort 1a: determine the organ dosimetry of 68Ga-FAP-2286. 3. Cohort 1b: determine the organ dosimetry of 64Cu-FAP-2286…
Inclusion Criteria: 1. Age \>= 18 years. 2. Histopathologically confirmed solid tumors in one of the following cohorts: a. Cohort 1 (n=11): measurable disease is not required for this cohort. i. Agnostic to tumor type. b. Cohort 2 (n=95): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study. i. Pathologically confirmed breast…
The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Participants will be scanned for approximately 30 to 45 minutes
The dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Arctuva estimate
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