[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
Recruiting · NCT07215182 · Interventional (participants receive a specific treatment) · Lead sponsor: Barbara Malene Fischer
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed.
- Rigshospitalet - Copenhagen, Ca, Denmark
- Herlev Universityhospital - Herlev, Capital Region, Denmark