Use of a New Diagnostic Tool in the Detection and Characterization of Endometriosis Lesions

NCT ID: NCT07053982

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-10-31

Brief Summary

Diagnostic wandering is one of the characteristics of endometriosis due to great anatomical and clinical variability but also due to poorly relevant diagnostic examinations. [18F]-FES PET/CT could on the one hand improve diagnosis by showing greater sensitivity than MRI and on the other hand make it possible to quantify and characterize the expression of ER from diagnosis and thus helping to guide therapeutic care. We will thus attempt to correlate the intensity of [18F]-FES PET/CT with the expression of estrogen receptors and the intensity of pain.

Detailed Description

Endometriosis is a chronic estrogen-dependent gynecological condition that leads to impaired overall quality of life due to infertility and associated pain. Diagnostic wandering is one of the characteristics of endometriosis due to great anatomical and clinical variability but also due to poorly relevant diagnostic examinations. There are several anatomo-clinical pathological entities. Thus, its painful symptoms vary greatly in its location and intensity. MRI, the reference examination for diagnosis but operator dependent, shows imperfect sensitivity. The diagnosis and characterization of lesions must therefore be improved. We know that 17β-estradiol, a key hormone for lesion growth, can also be produced locally by endometriotic tissue. The hypothesis according to which this local accumulation of estrogens plays an important role in the development of lesions by modulating the expression of RE must be studied. The use of new tools to study estrogen receptor expression should be evaluated at diagnosis. A new examination, [18F]-FES PET/CT, could on the one hand improve diagnosis by showing greater sensitivity than MRI and on the other hand make it possible to quantify and characterize the expression of the ER from the diagnosis and thus help to guide therapeutic care. [18F]-FES PET/CT is a non-invasive, operator-independent method that visualizes and quantifies ER expression in multiple tumors. Some studies have shown that [18F]-FES uptake correlates well with ER expression measured by immunohistochemistry staining. We will thus attempt to correlate the intensity of [18F]-FES PET/CT with the expression of estrogen receptors and the intensity of pain.

Conditions

Endometriosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Endometriosis Patients Undergoing Surgery for Severe Pain Management (EVA ≥ 4)

Group Type: EXPERIMENTAL

Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery

Intervention Type: PROCEDURE

This study includes preoperative \[18F\]-FES PET/CT imaging to assess estrogen receptor expression in endometriosis patients undergoing laparoscopic or robot-assisted surgery. Pain levels will be evaluated using VAS, BPI, HADS, and SF-36 scales. Immunohistochemistry and quantitative mRNA expression analysis (ESR1, ESR2, GPER) will be performed on excised lesions using Tissue Microarray. This approach aims to correlate PET/CT imaging findings with histological and molecular data, distinguishing it from standard surgical interventions.

Endometriosis Patients Undergoing Surgery for Infertility Without Severe Pain (EVA < 4)

Group Type: EXPERIMENTAL

Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery

Intervention Type: PROCEDURE

This study includes preoperative \[18F\]-FES PET/CT imaging to assess estrogen receptor expression in endometriosis patients undergoing laparoscopic or robot-assisted surgery. Pain levels will be evaluated using VAS, BPI, HADS, and SF-36 scales. Immunohistochemistry and quantitative mRNA expression analysis (ESR1, ESR2, GPER) will be performed on excised lesions using Tissue Microarray. This approach aims to correlate PET/CT imaging findings with histological and molecular data, distinguishing it from standard surgical interventions.

Interventions

Preoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis Surgery

This study includes preoperative \[18F\]-FES PET/CT imaging to assess estrogen receptor expression in endometriosis patients undergoing laparoscopic or robot-assisted surgery. Pain levels will be evaluated using VAS, BPI, HADS, and SF-36 scales. Immunohistochemistry and quantitative mRNA expression analysis (ESR1, ESR2, GPER) will be performed on excised lesions using Tissue Microarray. This approach aims to correlate PET/CT imaging findings with histological and molecular data, distinguishing it from standard surgical interventions.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariane WEYL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Toulouse, Rangueil Hospital

Toulouse, , France

Countries

France

Central Contacts

Ariane Weyl

Role: CONTACT

weyl.a@chu-toulouse.fr

05 61 32 21 48 ext. +33

Caroline Peyrot

Role: CONTACT

peyrot.c@chu-toulouse.fr

+33 (0)5 61 77 84 86 ext. +33

Facility Contacts

Ariane Weyl

Role: primary

weyl.a@chu-toulouse.fr

+33 (0)5 61 32 21 48

Other Identifiers

2025-520637-24-00

Identifier Type: CTIS

Identifier Source: secondary_id

RC31/23/0622

Identifier Type: -

Identifier Source: org_study_id