Imaging of Solid Tumors Using 68Ga-FAP-2286
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Cancer
- Solid Tumors, Adult
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 determine the dosimetry for gallium-68 labelled (68Ga-) FAP-2286, evaluate the uptake and retention of radiotracer in a variety of solid ...
Initially the investigator(s) will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer. STUDY AIMS determine the dosimetry for gallium-68 labelled (68Ga-) FAP-2286, evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286, and evaluate the ability of FAP-2286 to detect metastatic disease. PRIMARY OBJECTIVES All cohorts: Safety of 68Ga-FAP-2286 Cohort 1: determine the organ dosimetry of 68Ga-FAP-2286 Cohort 2: determine the feasibility of detecting tumor uptake using 68Ga-FAP-2286 Cohort 3: determine the feasibility of detecting metastatic disease using 68Ga-FAP-2286 EXPLORATORY OBJECTIVES Correlation of 68Ga-FAP-2286 uptake with FAP expression determined by immunohistochemistry. Compare 68Ga-FAP-2286 scan results to archival Fluorodeoxyglucose (FDG)-PET images. Compare biodistribution of 68Ga-FAP-2286 in normal organs and blood pool based on renal function. 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.
Tracking Information
- NCT #
- NCT04621435
- Collaborators
- Clovis Oncology, Inc.
- Investigators
- Principal Investigator: Thomas Hope, MD University of California, San Francisco