Using FAPI PET-CT to diagnose endometriosis
Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patient with Endometriosis
This study is testing a new imaging method called FAPI PET-CT to see if it can help diagnose endometriosis in patients before they have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Ziv Hospital Government |
| Drugs / interventions | Radiation |
| Locations | 1 site (Safed) |
| Trial ID | NCT06792318 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of FAPI PET-CT imaging for diagnosing endometriosis in patients scheduled for surgery. Participants will receive a single injection of FAPI and undergo multiple imaging sessions to assess the presence of endometriotic lesions. The results from the imaging will be compared with surgical findings and pathology to determine accuracy. The study aims to provide a non-invasive method for better pre-operative planning and lesion mapping.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-45 with clinical suspicion of endometriosis who are scheduled for laparoscopic surgery.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of pelvic radiation therapy or active malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and less invasive diagnosis of endometriosis, improving patient outcomes.
How similar studies have performed: While the use of FAPI PET-CT is a novel approach in this context, similar imaging techniques have shown promise in other diagnostic applications.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Safed
- Ziv Medical Center — Safed, Israel (Recruiting)
Study contacts
- Study coordinator: Israel Sandler, MD
- Email: israels@ziv.gov.il
- Phone: +972-527-362280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.