Contribution of PET (Positron Emission Tomography) Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN

NCT04831619 | Completed Phase 3 DMC

• 1 other identifier: 2013/CHU/12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Endometriosis is an inflammatory condition that is often treated by surgery. MRI and ultrasound are used for the preoperative morphological assessment. Currently, only surgery allows the exhaustive and qualitative diagnosis of lesions. The PET scan, fixing in certain inflammatory pathologies and in certain cases of endometriosis, could refine this assessment by evaluating the location of the lesions.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.

  Total number of endometriosis lesions diagnosed by the PET scanner

  at inclusion (before surgery)

Secondary Outcomes (3)

• Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions

  up to 14 weeks (after surgery)

• Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions

  up to 14 weeks (after surgery)

• Define a reading threshold of SUV (Standardized Uptake Value) on a PET scanner for the diagnosis of endometriosis

  up to 14 weeks (after PET-Scanner)

Study Arms (1)

PET scanner in addition to MRI

EXPERIMENTAL

Drug: PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)

Interventions

PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel) DRUG

A PET scan will be performed in the patients included, in addition to the conventional imaging workup (MRI, endovaginal and pelvic ultrasound).

PET scanner in addition to MRI

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient aged over 18 and under 50
• Patient with symptomatic endometriosis with indication for surgery
• Showing at least one typical endometriosis lesion on MRI, greater than 5mm
• Accepting surgical management
• Having signed an informed consent after information
• Affiliate or beneficiary of a social security scheme

You may not qualify if:

• Patient who has received an injection with GnRH (gonadotropin-releasing hormone ) analogues for less than 3 months (because it induces the quiescence of the disease which is no longer stimulated by estrogen secretion)
• Patient with a history of heavy abdominopelvic surgery
• Diabetic patient
• Patient unable to understand the interest of the study
• Patient already included in another therapeutic trial with an experimental molecule.
• Persons referred to in articles L1121-5 to L1121-8 of the PHC (public health code) (corresponding to all protected persons: pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, minor, and person making the subject to a legal protection measure: guardianship or curators)
• Contraindications to PET Scanner (major claustrophobia, contraindication or hypersensitivity to 18-FDG or one of its excipients, contraindication or hypersensitivity to Ultravist® or one of its excipients, etc.)
• Contraindication to surgery or anesthesia

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (2)

Centre Hospitalier Universitaire Réunion

Saint-Denis, 97400, France

Location

CHU de la Réunion

Saint-Pierre, 97448, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 5, 2021
• Study Start: December 12, 2023
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)