Total-body PET/CT with [68Ga]Ga-FAPI-46 for faster, clearer imaging in advanced melanoma
Official title: [68Ga]Ga-FAPI PET/CT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma
Run by Copenhagen University Hospital, Rigshospitalet · NCT07215182 · Data updated 2026-11-12
This will test whether [68Ga]Ga-FAPI-46 PET/CT can more quickly and accurately show treatment response in adults with stage IV malignant melanoma receiving immune checkpoint inhibitors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 2 sites (Herlev, Capital Region and 1 other locations) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | August 20, 2026 |
| Study ends | February 20, 2027 |
| Registry record updated | October 10, 2025 |
| Trial ID | NCT07215182 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed inoperable or metastatic malignant melanoma who have visible lesions on standard imaging and are scheduled to start immune checkpoint inhibitor therapy are ideal candidates.
✕Probably not a fit
Patients with ocular or mucosal melanoma, those who have already received immune checkpoint therapy, people with other active cancers, pregnant or breastfeeding individuals, those over the PET/CT weight limit, or with relevant allergies are excluded and would not benefit from this specific test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 interventional study enrolls adults with histologically confirmed inoperable or metastatic (stage IV) malignant melanoma who are planned for immune checkpoint inhibitor therapy. Participants receive a [68Ga]Ga-FAPI-46 PET/CT scan before starting treatment and a second scan three months later, with two blood samples collected and passive follow-up six months after the last FAPI scan. Findings on the experimental FAPI PET/CT will be compared with standard [18F]FDG PET/CT or CT to see if FAPI provides clearer or earlier signs of response. The main aim is to determine whether [68Ga]Ga-FAPI-46 can act as an imaging biomarker to improve response evaluation during immunotherapy.
Why it matters
Potential benefit: If successful, this imaging approach could let doctors detect immunotherapy response earlier and with greater clarity, helping tailor treatments sooner.
How similar studies have gone: Early studies using FAPI PET tracers across various cancers have reported promising tumor-to-background contrast and faster imaging than FDG, but application specifically for monitoring immunotherapy in advanced melanoma remains limited and under active study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, \>/=18 years old 2. Histological verified metastatic or locally advanced malignant melanoma 3. Visible malignant lesions on \[18F\]FDG PET/CT or CT 4. Subjects must be considered inoperable 5. Subjects must be considered medically suitable for ICT 6. Subjects must be able to read and understand the patient information in Danish to give informed consent Exclusion Criteria: 1. Ocular or mucosal melanoma 2. Other concurrent cancer disease 3. Previous systemic oncological treatment with ICT 4. Pregnancy or lactation 5. Weight more than the maximum limit of a PET/CT-scanner bed (140 kg) 6. History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI- 46
Where it's running
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Herlev Universityhospital
Herlev, Capital Region, Denmark Recruiting -
Rigshospitalet
Copenhagen, Ca, Denmark Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.