Contribution of PET Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN

Centre Hospitalier Universitaire de la Réunion2 sites in 1 country10 target enrollmentMay 2022

ConditionsEndometriosis

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

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

Overview

Phase: Phase 3
Intervention: PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)
Conditions: Endometriosis
Sponsor: Centre Hospitalier Universitaire de la Réunion
Enrollment: 10
Locations: 2
Primary Endpoint: To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2022

End Date

September 30, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Centre Hospitalier Universitaire de la Réunion

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

PET scanner in addition to MRI

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

Outcomes

Primary Outcomes

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

Time Frame: at inclusion (before surgery)

Total number of endometriosis lesions diagnosed by the PET scanner

Secondary Outcomes

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))
Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions(up to 14 weeks (after surgery))