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

Study acronym: BEFAST
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 10, 2025 (before its estimated August 20, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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
(from sponsor)		 Malignant Melanoma Stage IV
Related terms Melanoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov