RecruitingPhase 2NCT07215182

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

[68Ga]Ga-FAPI PET/CT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma


Sponsor

Barbara Malene Fischer

Enrollment

20 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of full-body PET/CT scan using a tracer called [68Ga]Ga-FAPI-46 — which lights up cancer tissue by targeting proteins expressed around tumors — to see if it provides better and faster imaging than standard scans for people with advanced melanoma who are about to start immunotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed advanced or metastatic melanoma (spread to other organs) - Your cancer is visible on standard scans and is considered inoperable - You are considered medically suitable for immunotherapy - You can read and understand Danish to give informed consent **You may NOT be eligible if...** - You have ocular (eye) or mucosal melanoma - You have another active cancer at the same time - You have previously received immunotherapy for your cancer - You are pregnant or breastfeeding - You weigh more than 140 kg - You have had an allergic reaction to similar imaging tracers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[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

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NCT07215182


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