NCT05160051

68Ga-FAPI-46 PET for Imaging of FAP Expressing Cancer

68Ga-FAPI-46 PET for Imaging of FAP Expressing Cancer: A Single-center Prospective Interventional Single-arm Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to explore the safety and tolerability as well as diagnostic accuracy of 68Ga-FAPI-46 for different FAP-expressing tumor entities by PET. This study does not offer any treatment for patients with FAP-expressing carcinomas; therefore, patients will be offered state of the art therapeutic options. Routine surgery will be performed within 8 weeks after 68Ga-FAPI-46 PET.

Detailed description

Primary Endpoint: Positive predictive value (PPV) on a per-region- and per-patient-basis of 68Ga-FAPI-46 PET for detection of histopathology-FAPpositive tumor lesions, confirmed by histopathology/biopsy (reached for ≥ 75%). Secondary Endpoints: 1. Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression 2. Sensitivity and specificity of 68Ga-FAPI-46 PET on a per-patient and per-region-basis for detection of histopathology-FAPpositive tumor lesions confirmed by histopathology/biopsy (separate for regional, extra-regional and distant locations) 3. Detection rate of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor location, also stratified by tumor maker serum level 4. Sensitivity and specificity of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumor lesions confirmed by combined histopathology/biopsy/follow-up imaging/clinical follow-up reference standard (separate for regional, extra-regional and distant locations) 5. Impact on management 6. Inter-reader reproducibility 7. Safety 8. Change in staging/prognostic groups

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-FAPI-46 PET Scan	68Ga-FAPI-46 is a radiotracer that binds with high affinity to Fibroblast Activating Protein (FAP). FAP is physiologically expressed in many tissues during embryonic development, but in adults it is expressed only in the context of wound healing, fibrotic processes, and the stroma of many malignancies. Therefore, the study seeks to validate if 68Ga-FAPI-46 PET could be established as a diagnositc tool to detect solid tumors.

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-03-06
• Completion: 2024-03-06
• First posted: 2021-12-16
• Last updated: 2024-04-12

Locations

1 site across 1 country: Germany