NCT07215182RecruitingPhase 2
[68Ga]Ga-FAPI PET/CT for response evaluation during immune checkpoint inhibitor therapy in malignant melanoma
BEFAST STUDY: [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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 May 2026
Brief summary (registry, in English)
The overall aim of the study is to evaluate Total Body (TB) positron emission tomography/computed tomography (PET/CT) combined with the tracer [68Ga]Ga-FAPI-46 for response evaluation during immune checkpoint inhibitor therapy (ICT) in patients with advanced stage malignant melanoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 27 Nov 2024
- Start date
- 3 Aug 2025
- Lead sponsor
- Rigshospitalet
- Diseases
- Melanoma
- EU CT number
- 2023-509549-11-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concurrent cancer disease
Other illness
- History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46
Other
- Ocular or mucosal melanoma
- Pregnancy or lactation
- Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
Who the study is looking for
- 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 medically suitable for ICT (either Pembrolizumab or Ipilimumab+Nivolumab)
- Subjects must be able to read and understand the patient information in Danish to give informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.