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RECRUITING
NCT07215182
PHASE2

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

Sponsor: Barbara Malene Fischer

View on ClinicalTrials.gov

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

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