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Recruiting Phase 2

[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer

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About this study

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

Condition
Malignant Melanoma Stage IV
Tested
[68Ga]Ga-FAPI-46
Sponsor
Barbara Malene Fischer

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Study condition: Malignant Melanoma Stage IV
  • 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 6

  • 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

2 sites, 2 recruiting

Rigshospitalet

Copenhagen, Ca, Denmark

Recruiting

Herlev Universityhospital

Herlev, Capital Region, Denmark

Recruiting

Potential match only. Final eligibility is determined by the study team.