Status:
RECRUITING
[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
Lead Sponsor:
Barbara Malene Fischer
Collaborating Sponsors:
Herlev Hospital
Conditions:
Malignant Melanoma Stage IV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 imm...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07215182
Start Date
August 15 2025
End Date
February 20 2027
Last Update
October 10 2025
Active Locations (2)
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1
Herlev Universityhospital
Herlev, Capital Region, Denmark, 2730
2
Rigshospitalet
Copenhagen, Ca, Denmark, 2100