(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Malignant melanoma

Inclusion criteria

• {"criterion_text":"- Male or female, > 18 years old"}
• {"criterion_text":"- Histological verified metastatic or locally advanced malignant melanoma"}
• {"criterion_text":"- Visible malignant lesions on [18F]FDG PET/CT or CT"}
• {"criterion_text":"- Subjects must be considered medically suitable for ICT (either Pembrolizumab or Ipilimumab+Nivolumab)"}
• {"criterion_text":"- Subjects must be able to read and understand the patient information in Danish to give informed consent"}

Exclusion criteria

• {"criterion_text":"- Ocular or mucosal melanoma"}
• {"criterion_text":"- Other concurrent cancer disease"}
• {"criterion_text":"- Pregnancy or lactation"}
• {"criterion_text":"- Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)"}
• {"criterion_text":"- History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46"}

Primary endpoints

• {"endpoint_text":"- Evaluate [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT.","definition_or_measurement_approach":"Assessment of [68Ga]Ga-FAPI-46 uptake in malignant lesions using [68Ga]Ga-FAPI-46 PET/CT imaging."}
• {"endpoint_text":"- Evaluate changes in [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT.","definition_or_measurement_approach":"Longitudinal comparison of [68Ga]Ga-FAPI-46 PET/CT uptake in lesions during immune checkpoint inhibitor therapy (ICT)."}
• {"endpoint_text":"- Compare the changes in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT with changes on standard [18F]FDG PET/CT and clinical response during ICT.","definition_or_measurement_approach":"Comparison of imaging-based changes on [68Ga]Ga-FAPI-46 PET/CT versus [18F]FDG PET/CT and correlation with clinical response assessments during ICT."}

Secondary endpoints

• {"endpoint_text":"- Changes in [68Ga]Ga-FAPI-46 uptake during ICT in healthy tissue as a predictor of potential side effects.","definition_or_measurement_approach":"Assessment of [68Ga]Ga-FAPI-46 uptake changes in healthy tissues on PET/CT during ICT and evaluation as predictor of side effects."}
• {"endpoint_text":"- Compare changes on [68Ga]Ga-FAPI-46 PET/CT in healthy tissue with changes on standard [18F]FDG PET/CT.","definition_or_measurement_approach":"Comparative analysis of uptake changes in healthy tissue between [68Ga]Ga-FAPI-46 PET/CT and [18F]FDG PET/CT."}
• {"endpoint_text":"- Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of FAP activity biomarkers in serum blood samples.","definition_or_measurement_approach":"Correlation analysis between measured PET tracer uptake and serum FAP activity biomarker levels."}
• {"endpoint_text":"- Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of other biomarkers (e.g. ECM remodeling biomarkers) in serum blood samples.","definition_or_measurement_approach":"Correlation analysis between PET tracer uptake and specified serum biomarkers (e.g., ECM remodeling markers)."}
• {"endpoint_text":"- Correlation between levels of biomarkers in serum blood samples and treatment outcome.","definition_or_measurement_approach":"Correlation analysis between serum biomarker levels and clinical treatment outcomes."}

Denmark

Earliest CTIS Part Ii Submission Date

25-02-2025

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

444

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}