The Role of FAPI PET-CT in Diagnosing Endometriosis

Ziv Hospital

Status: Enrolling

Conditions: Endometriosis

Treatments: Diagnostic Test: FAPI PET-CT

Study type: Interventional

Funder types: Other

Identifiers

NCT06792318

101-24-ZIV

IRB Number 101-24-ZIV (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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 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 to enrollment

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

FAPI PET-CT Diagnostic Arm

Experimental group

Description:

Participants undergo FAPI PET-CT imaging at multiple timepoints (10, 30, 60, and 80 minutes post-injection) using a single FAPI dose. Each participant will then undergo laparoscopic surgery with tissue sampling for pathological confirmation of endometriotic lesions.

Treatment:

Diagnostic Test: FAPI PET-CT