Spots Global Cancer Trial Database for Imaging of Solid Tumors Using FAP-2286

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Trial Identification

Brief Title: Imaging of Solid Tumors Using FAP-2286

Official Title: Imaging of Solid Tumors Using FAP-2286

Study ID: NCT04621435

Conditions

Solid Tumors, Adult

Metastatic Cancer

Interventions

Gallium-68 labelled (68Ga-) FAP-2286

Positron Emission Tomography (PET) imaging

Copper-64 labeled (64Cu-) FAP-2286

Study Description

Brief Summary: 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.

Detailed Description: 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. 4. Cohort 2: To assess the feasibility of detecting tumor uptake using FAP-2286. 5. Cohort 3: To determine the feasibility of detecting metastatic disease using FAP-2286. EXPLORATORY OBJECTIVES 1. To detect the sensitivity of FAP-2286 PET compared to conventional imaging for the detection of metastatic disease, and when available sensitivity compared to Fluorodeoxyglucose (FDG) PET (FDG-PET). 2. Correlation of FAP-2286 uptake with FAP expression determined by immunohistochemistry. 3. Compare biodistribution of 68Ga-FAP-2286 and 64Cu-FAP-2286 in normal organs and blood pool based on renal function. 4. Determine impact of administered dose of FAP-2286 on image quality. 5. Compare the feasibility of detecting tumor uptake using 68Ga-FAP-2286 and 64Cu-FAP-2286 A repeat radiolabeled 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 radiolabeled ligand for evaluation of adverse events.