Imaging Test Checks Melanoma Response to Immune Therapy in Adults
Tests a tracer scan, 68Ga-FAPI-46 PET/CT, in adults with advanced melanoma on immune therapy.
Plain-language title generated from the registry record
Registry title: [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
Key facts
- Where
- Copenhagen Oe and Herlev, DenmarkSee the 2 sites
- Phase
- Phase 2
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Herlev HospitalHerlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Barbara Malene Fischer
- Trial code
- NCT07215182EU 2023-509549-11-00
- Record updated
- 10 October 2025
- Original description
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:Read full original descriptionShow less
[68Ga]Ga-FAPI PET/CT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma
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
Inclusion: 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: Other concurrent cancer disease; Previous systemic oncological treatment with ICT; History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI- 46; Ocular or mucosal melanoma; Pregnancy or lactation; Weight more than the maximum limit of a PET/CT-scanner bed (140 kg).