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[68Ga]Ga-FAPI PET/CT for response evaluation during immune checkpoint inhibitor therapy in malignant melanoma
EU CTIS ID: 2023-509549-11-00
What this study is testing
The overall aim of the study is to evaluate Total Body (TB) positron emission tomography/computed tomography (PET/CT) combined with the tracer [68Ga]Ga-FAPI-46 for response evaluation during immune checkpoint inhibitor therapy (ICT) in patients with advanced stage malignant melanoma.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 medically suitable for ICT (either Pembrolizumab or Ipilimumab+Nivolumab)
- Subjects must be able to read and understand the patient information in Danish to give informed consent
You likely can't join if
- Ocular or mucosal melanoma
- Other concurrent cancer disease
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.