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

Sponsor
University Hospital, Toulouse
Study ID
NCT07053982
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 8, 2025
Start date
Mar 23, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Endometriosis Patients Undergoing Surgery for Severe Pain Management (EVA ≥ 4)
  • Experimental: Endometriosis Patients Undergoing Surgery for Infertility Without Severe Pain (EVA < 4)

Primary Outcome Measure

Quantification of Estrogen Receptor Overexpression in Endometriotic Lesions Using SUV on [18F]-FES PET/CT [ Time Frame: Preoperative assessment at mid-cycle, before surgery and without concurrent hormonal treatment. ]

Central Contacts

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