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BEFAST STUDY: [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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509549-11-00
Enrollment
20
Registered
2025-03-07
Start date
2025-08-03
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant melanoma

Brief summary

Evaluate [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT., Evaluate changes in [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT., 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.

Detailed description

Changes in [68Ga]Ga-FAPI-46 uptake during ICT in healthy tissue as a predictor of potential side effects., Compare changes on [68Ga]Ga-FAPI-46 PET/CT in healthy tissue with changes on standard [18F]FDG PET/CT., Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of FAP activity biomarkers in serum blood samples., 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., Correlation between levels of biomarkers in serum blood samples and treatment outcome.

Interventions

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Evaluate [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT., Evaluate changes in [68Ga]Ga-FAPI-46-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT., 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.

Secondary

MeasureTime frame
Changes in [68Ga]Ga-FAPI-46 uptake during ICT in healthy tissue as a predictor of potential side effects., Compare changes on [68Ga]Ga-FAPI-46 PET/CT in healthy tissue with changes on standard [18F]FDG PET/CT., Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of FAP activity biomarkers in serum blood samples., 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., Correlation between levels of biomarkers in serum blood samples and treatment outcome.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026