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[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
Sponsor: Barbara Malene Fischer
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
Official title: [68Ga]Ga-FAPI PET/CT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-08-15
Completion Date
2027-02-20
Last Updated
2025-10-10
Healthy Volunteers
No
Conditions
Interventions
[68Ga]Ga-FAPI-46
Patients undergo two PET/CTs with the experimental tracer \[68Ga\]Ga-FAPI-46 (drug).
Locations (2)
Herlev Universityhospital
Herlev, Capital Region, Denmark
Rigshospitalet
Copenhagen, Ca, Denmark