NCT07372963

18F-FAPI PET in Cancers of Unknown Primary Site

Prospective Clinical Study and Exploration of 18F-FAPI PET/CT Imaging in Cancers of Unknown Primary Site

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary.

Detailed description

Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT in patients with undetermined primary tumor (sensitivity, specificity, accuracy). secondary end points: * The diagnostic performance of 18F-FAPI PET/CT compared with CT, MR and 18F-FDG PET in the clinical application of cancer with unknown primary site was compared. ④Assess the heterogeneity of sensitivity and specificity of 18F-FAPI PET/CT for different system sites (neck/thorax/abdomen). * Study on efficacy evaluation and prognostic prediction of 18F-FAPI PET/CT in patients with primary tumors of unknown origin.

Conditions

• Cancer of Unknown Primary Site

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-FAPI PET	18F-FAPI-04 PET/CT

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: China