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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

Malignant Melanoma Stage IV

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

Inclusion Criteria6

  • Male or female, \>/=18 years old
  • Histological verified metastatic or locally advanced malignant melanoma
  • Visible malignant lesions on \[18F\]FDG PET/CT or CT
  • Subjects must be considered inoperable
  • Subjects must be considered medically suitable for ICT
  • Subjects must be able to read and understand the patient information in Danish to give informed consent

Exclusion Criteria6

  • Ocular or mucosal melanoma
  • Other concurrent cancer disease
  • Previous systemic oncological treatment with ICT
  • Pregnancy or lactation
  • Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
  • History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI- 46

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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