The Role of FAPI PET-CT in Diagnosing Endometriosis

Last updated: January 22, 2025
Sponsor: Ziv Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

FAPI PET-CT

Clinical Study ID

NCT06792318
101-24-ZIV
IRB Number 101-24-ZIV
  • Ages 18-45
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female participants aged 18-45 years

  • Clinical suspicion of endometriosis based on symptoms

  • Scheduled for diagnostic/therapeutic laparoscopic surgery

  • Ability to understand and provide written informed consent

  • Completed and signed Radiation Exposure Documentation Form

Exclusion

Exclusion Criteria:

  • Pregnant women or women who are breastfeeding

  • History of pelvic radiation therapy

  • Known active malignancy

  • Exposure to ionizing radiation for medical purposes within 12 months prior toenrollment

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: FAPI PET-CT
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Ziv Medical Center

    Safed, 13100
    Israel

    Active - Recruiting

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