[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
ConditionMalignant Melanoma Stage IV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarbara Malene Fischer
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Ocular or mucosal melanoma
Other concurrent cancer disease
Previous systemic oncological treatment with ICT
Pregnancy or lactation
Trial design
Treatments tested in this trial
- [68Ga]Ga-FAPI-46
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Barbara Malene Fischer
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Herlev Hospital
Collaborator
Source ClinicalTrials.gov