New [18F]-FES PET/CT imaging to detect and describe endometriosis lesions
18F]-FES PET in the Detection and Characterization of Endometriosis Lesions
This study will test whether an [18F]-FES PET/CT scan can better find endometriosis lesions and measure estrogen receptor activity in adults scheduled for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT07053982 on ClinicalTrials.gov |
What this trial studies
Participants will undergo a preoperative [18F]-FES PET/CT scan in addition to standard MRI, with images compared to surgical and pathology findings to locate and characterize lesions. The study will correlate PET uptake with tissue estrogen receptor expression measured on surgical specimens and with patient-reported pain intensity. Enrollment includes symptomatic cases (VAS ≥ 4) and control patients treated surgically for infertility (VAS < 4), with imaging performed mid-cycle when possible. The approach aims to determine whether [18F]-FES PET/CT improves lesion detection and provides quantitative receptor information that could guide treatment.
Who should consider this trial
Good fit: Adults over 18 undergoing surgery for endometriosis who can have a preoperative MRI and [18F]-FES PET/CT, are not menopausal or on hormone therapy, and can provide informed consent are ideal candidates.
Not a fit: Patients who are pregnant, menopausal, currently on hormone therapy, managed without surgery, claustrophobic, or allergic to the tracer are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the test could improve diagnostic accuracy, shorten diagnostic delay, and help personalize hormonal treatment by showing lesion estrogen receptor expression.
How similar studies have performed: [18F]-FES PET/CT has shown good correlation with estrogen receptor expression in breast cancer, but its application to endometriosis is novel and data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cases: \- Painful patients with a VAS ≥ 4 treated surgically for painful symptoms related to endometriosis; Controls: * Patient with a VAS \< 4 treated surgically for endometriosis in the context of infertility; * Age \> 18 years; * Patient who provided informed consent; * Patients who underwent a preoperative MRI and were not contraindicated for \[18F\]-FES PET/CT; * Patient who underwent surgery mid-cycle; * Affiliation to a social security scheme Exclusion Criteria: * Patient treated for endometriosis without surgery; * Pregnant patient * Patient taking hormone therapy * Menopausal patient * Hypersensitivity to the active substance (Fluoroestradiol (18F)) or to any of the excipients * Patient under legal protection * Claustrophobic patient
Where this trial is running
Toulouse
- Toulouse, Rangueil Hospital — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Ariane WEYL, MD — University Hospital, Toulouse
- Study coordinator: Ariane Weyl
- Email: weyl.a@chu-toulouse.fr
- Phone: 05 61 32 21 48
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.