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OncoMatch/Clinical Trials/NCT07215182

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

Is NCT07215182 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies [68Ga]Ga-FAPI-46 for malignant melanoma stage iv.

Phase 2RecruitingBarbara Malene FischerNCT07215182Data as of May 2026

Treatment: [68Ga]Ga-FAPI-46The 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

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Extracted eligibility criteria

Cancer type

Melanoma

Disease stage

Required: Stage IV

Metastatic disease required

Histological verified metastatic or locally advanced malignant melanoma

Prior therapy

Cannot have received: immune checkpoint inhibitor

Previous systemic oncological treatment with ICT

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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