Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 2INTERVENTIONAL

[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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female, \>/=18 years old 2. Histological verified metastatic or locally advanced malignant melanoma 3. Visible malignant lesions on \[18F\]FDG PET/CT or CT 4. Subjects must be considered inoperable 5. Subjects must be considered medically suitable for ICT 6. Subjects must be able to read and understand the patient information in Danish to give willing to sign a consent form Who Should NOT Join This Trial: 1. Ocular or mucosal melanoma 2. Other concurrent cancer disease 3. Previous systemic oncological treatment with ICT 4. Pregnancy or lactation 5. Weight more than the maximum limit of a PET/CT-scanner bed (140 kg) 6. History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI- 46 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Male or female, \>/=18 years old 2. Histological verified metastatic or locally advanced malignant melanoma 3. Visible malignant lesions on \[18F\]FDG PET/CT or CT 4. Subjects must be considered inoperable 5. Subjects must be considered medically suitable for ICT 6. Subjects must be able to read and understand the patient information in Danish to give informed consent Exclusion Criteria: 1. Ocular or mucosal melanoma 2. Other concurrent cancer disease 3. Previous systemic oncological treatment with ICT 4. Pregnancy or lactation 5. Weight more than the maximum limit of a PET/CT-scanner bed (140 kg) 6. History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI- 46

Treatments Being Tested

DRUG

[68Ga]Ga-FAPI-46

Patients undergo two PET/CTs with the experimental tracer \[68Ga\]Ga-FAPI-46 (drug).

Locations (2)

Herlev Universityhospital
Herlev, Capital Region, Denmark
Rigshospitalet
Copenhagen, Ca, Denmark