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RecruitingNCT07053982

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

18F]-FES PET in the Detection and Characterization of Endometriosis Lesions

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREPreoperative [18F]-FES PET/CT Imaging and Estrogen Receptor Expression Analysis in Endometriosis SurgeryThis 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.

Timeline

Start date
2026-03-23
Primary completion
2028-03-01
Completion
2028-03-01
First posted
2025-07-08
Last updated
2026-03-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07053982. Inclusion in this directory is not an endorsement.