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

Phase 3

Not yet recruiting

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

• Registration Number: NCT04831619
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02
• Study Start: 2022-05
• Primary Completion: 2023-05
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET scanner in addition to MRI	PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)	-

Primary Outcome Measures

Name	Time	Method
To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.	at inclusion (before surgery)	Total number of endometriosis lesions diagnosed by the PET scanner

Secondary Outcome Measures

Name	Time	Method
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)	degree of inflammation of the cells
Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions	up to 14 weeks (after surgery)	location of endometriosis lesions

Trial Locations

Locations (2)

Centre Hospitalier Universitaire Réunion; 🇫🇷 Saint-Denis, France

CHU de la Réunion; 🇫🇷 Saint-Pierre, France