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

NCT ID: NCT04831619

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET scanner in addition to MRI

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire Réunion

Saint-Denis, , France

CHU de la Réunion

Saint-Pierre, , France

Countries

France

Central Contacts

Lucie AUZANNEAU

Role: CONTACT

lucie.auzanneau@chu-reunion.fr

(0)262 35 99 49 ext. +33

Facility Contacts

Lucie AUZANNEAU

Role: primary

lucie.auzanneau@chu-reunion.fr

(0)262 35 99 49 ext. +33

Lucie AUZANNEAU

Role: primary

lucie.auzanneau@chu-reunion.fr

(0)262 35 99 49 ext. +33

Other Identifiers

2013/CHU/12

Identifier Type: -

Identifier Source: org_study_id