Actively Recruiting
[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
Led by Barbara Malene Fischer · Updated on 2025-10-10
20
Participants Needed
2
Research Sites
79 weeks
Total Duration
On this page
Sponsors
B
Barbara Malene Fischer
Lead Sponsor
H
Herlev Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, ≥18 years old
- Histologically verified metastatic or locally advanced malignant melanoma
- Visible malignant lesions on [18F]FDG PET/CT or CT
- Considered inoperable by a physician
- Medically suitable for immune checkpoint inhibitor therapy
- Able to read and understand patient information in Danish to provide informed consent
You will not qualify if you...
- Ocular or mucosal melanoma
- Other concurrent cancer disease
- Previous systemic oncological treatment with immune checkpoint inhibitor therapy
- Pregnancy or lactation
- Weight exceeding the maximum limit of the PET/CT scanner bed (140 kg)
- History of allergic reaction to compounds similar to [68Ga]Ga-FAPI-46
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Herlev Universityhospital
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
2
Rigshospitalet
Copenhagen, Ca, Denmark, 2100
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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