Clinical Trial

[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer

Study acronym: BEFAST
Recruiting Phase 2
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Summary
The goal of this clinical trial is to investigate the use of the tracer \[68Ga\]Ga-FAPI-46 for PET/CT-imaging in response evaluation of patients with advanced stage malignant melanoma treated with immune checkpoint inhibitor therapy (ICT). The main question it aims to answer is: • Can \[68Ga\]Ga-FAPI-46 PET/CT improve response evaluation in patients suffering from advanced stage malignant melanoma treated with ICT and potentially serve as a biomarker. Researchers will compare findings on the experimental \[68Ga\]Ga-FAPI-46 PET/CT with findings on standard imaging (\[18F\]FDG PET/CT). Participants will undergo: * Two \[68Ga\]Ga-FAPI-46 PET/CT scans: one before treatment initiation with ICT and one after three months. * Two blood samples * Passive follow-up 6 months after the last scan \[68Ga\]Ga-FAPI-46 PET/CT
Trial Details
NCT Number NCT07215182
Lead Sponsor Barbara Malene Fischer
Collaborators: Herlev Hospital
Conditions Malignant Melanoma Stage IV
Enrollment 20 participants
Start Date 2025-08-15
Primary Completion 2026-08-20 (estimated)
Study Completion 2027-02-20 (estimated)
Updated on ClinicalTrials.gov 2025-10-10