NCT06792318

The Role of FAPI PET-CT in Diagnosing Endometriosis

Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patient with Endometriosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ziv Hospital · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Patients with suspected endometriosis scheduled for surgery will be identified. They will be asked to participate in a study evaluating the feasibility of FAPI PET-CT in diagnosing endometriosis. The results will be compared with surgical findings, pathology, and other imaging techniques if available (i.e., MRI, US).

Detailed description

This study investigates FAPI PET-CT imaging in endometriosis diagnosis using a standardized protocol. Participants will undergo two imaging sessions after a single FAPI injection: First Session: Initial scan at 10 minutes post-injection Follow-up scan at 30 minutes Second Session: Additional scans at 60 and 80 minutes post-injection The protocol is designed to minimize radiation exposure through: Single FAPI injection Two ultra-low dose CT scans Limited field of view to suspected areas. Nuclear medicine physicians will review PET-CT images independently, blinded to other imaging findings (MRI, US). Results will be shared with surgeons to guide the removal of suspicious lesions during surgery. All removed tissue will undergo pathological examination for confirmation. The study incorporates safety monitoring: Observation during and after FAPI administration Follow-up contact at 24-48 hours post-scan Documentation of any adverse events Immediate reporting of unexpected findings. This research could potentially provide evidence for a novel, non-invasive method to comprehensively map endometriotic lesions, improving pre-operative planning.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FAPI PET-CT	FAPI PET-CT imaging protocol: Single dose 68Ga/18F-FAPI (2 MBq/kg) Two imaging sessions: First: 10 and 30 minutes post-injection Second: 60 and 80 minutes post-injection Ultra-low dose CT for attenuation correction and anatomical localization

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: Israel