Actively Recruiting
Using 68GaGa-FAPI-46 PETCT Scans to Improve Response Evaluation During Immune Checkpoint Therapy for Advanced Malignant Melanoma
Led by Barbara Malene Fischer · Updated on 2025-10-10
20
Participants Needed
2
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the tracer 68GaGa-FAPI-46 in PETCT imaging to better assess how patients with advanced stage malignant melanoma respond to immune checkpoint inhibitor therapy ICT. The studys main goal is to determine if this new imaging method can improve response evaluation compared to the standard 18FFDG PETCT and possibly act as a biomarker for treatment effectiveness. Participants with advanced malignant melanoma will undergo two PETCT scans using the experimental tracer 68GaGa-FAPI-46 one before starting ICT treatment and another after three months. These scans are additional to their standard imaging. Blood samples will also be collected twice, and patients will receive standard ICT treatment as prescribed by their medical team. During the study, participants will have their scans and blood samples analyzed to observe changes in tracer uptake in both cancerous lesions and healthy tissues. Researchers will follow up passively for six months after the last PETCT scan to monitor outcomes. The primary outcome measured is the change in 68GaGa-FAPI-46 uptake in malignant lesions over a three-month period, with further monitoring extending to nine months total from enrollment.
CONDITIONS
Brief Title
[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
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