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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with melanoma that has spread or is advanced, cannot be operated on, and is about to start immune checkpoint inhibitor therapy. They get two extra [68Ga]Ga-FAPI-46 PET/CT scans.
- Age
- 18 years or older
- Sex
- Women and men can join
- Disease stage
- Melanoma proven by tissue test, spread to other parts of the body or locally advanced. Cancer must be visible on [18F]FDG PET/CT or CT. Surgery is not an option.
- Earlier treatment
- Must not have had immune checkpoint inhibitor therapy before. Must be considered medically fit to have it now.
Main reasons for not taking part
- Melanoma of the eye or of mucous membranes
- Another cancer at the same time
- Pregnancy or breastfeeding
- Weight above 140 kg (309 lb), the limit of the scanner bed
- Past allergic reaction to compounds similar to [68Ga]Ga-FAPI-46
Read by machine on 11 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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).