NCT07053982

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

June 10, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

June 10, 2025

Last Update Submit

March 24, 2026

Conditions

Endometriosis

Keywords

EndometriosisEstrogen receptorsPain[18F]-FES PET/CT

Outcome Measures

Primary Outcomes (1)

  • Quantification of Estrogen Receptor Overexpression in Endometriotic Lesions Using SUV on [18F]-FES PET/CT

    Estrogen receptor (ER) overexpression in endometriotic lesions will be assessed using the Standardized Uptake Value (SUV) on preoperative \[18F\]-FES PET/CT imaging. Each lesion's SUV will be quantified and compared within patients and between groups with high pain levels (VAS ≥ 4) and low or no pain (VAS \< 4). ER overexpression is defined as increased \[18F\]-FES uptake compared to background levels. The correlation between SUV values and pain severity will be analyzed to determine whether ER overexpression is associated with symptomatic burden. Higher SUV values indicate greater ER expression.

    Preoperative assessment at mid-cycle, before surgery and without concurrent hormonal treatment.

Secondary Outcomes (5)

  • Characterization of Lesion Staining by Immunohistochemistry and In Situ Hybridization: Intensity and Receptor Expression by Anatomical Location.

    From tissue collection at surgery to completion of immunohistochemical and in situ hybridization analyses (approximately 4 weeks post-surgery).

  • Sensitivity of [18F]-FES PET/CT Compared to MRI for Diagnosing Superficial and Deep Endometriotic Lesions by Anatomical Location.

    From completion of MRI and [18F]-FES PET/CT imaging (performed within 4 weeks prior to surgery) to histopathological analysis of lesions obtained during surgery (within 4 weeks post-imaging); total assessment period: up to 8 weeks per participant

  • Association Between [18F]-FES SUV Intensity, Estrogen Receptor Expression (IHC), and Pain Severity (VAS Score)

    From the date of [18F]-FES PET/CT imaging (≤4 weeks before surgery) to the date of surgery and completion of pain assessments (VAS and BPI) and histopathological analysis of surgical samples; total duration of assessment per participant : up to 8 weeks

  • Correlation Between Estrogen Receptor Expression in IHC/ISH and Pain Intensity (VAS) in Endometriosis

    From surgery (biopsy collection) to completion of pain assessment and histological analysis; up to 8 weeks.

  • Correlation Between Estrogen Receptor mRNA Expression and Pain Intensity (VAS) in Endometriosis

    From surgery (biopsy collection) to completion of ISH and VAS assessments; up to 8 weeks.

Study Arms (2)

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

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

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

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

Interventions

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

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse, Rangueil Hospital

Toulouse, 65360, France

RECRUITING

MeSH Terms

Conditions

EndometriosisPain

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ariane WEYL, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariane Weyl

CONTACT

05 61 32 21 48weyl.a@chu-toulouse.fr

Caroline Peyrot

CONTACT

+33 (0)5 61 77 84 86peyrot.c@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

July 8, 2025

Study Start

March 23, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)