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

Tumor, Solid Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Tumor, Solid

• NCT number: NCT05160051
• Study type: Interventional
• Source: University Hospital, Essen
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2021
• Completion date: March 6, 2024