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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Drug: PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lucie AUZANNEAU; Phone Number: +33 (0)262 35 99 49; Email: lucie.auzanneau@chu-reunion.fr

Study Locations

• France
  • Saint-Denis, France, 97400
    • Centre Hospitalier Universitaire Réunion
    • Contact: Lucie AUZANNEAU; Phone Number: +33 (0)262 35 99 49; Email: lucie.auzanneau@chu-reunion.fr
    • Principal Investigator: Peter VON THEOBALD, PHD
  • Saint-Pierre, France, 97448
    • CHU de la Réunion
    • Contact: Lucie AUZANNEAU; Phone Number: +33 (0)262 35 99 49; Email: lucie.auzanneau@chu-reunion.fr
    • Principal Investigator: Malik BOUKERROU, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET scanner in addition to MRI	Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions	number 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	location 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	degree of inflammation of the cells	up to 14 weeks (after PET-Scanner)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Radiopharmaceuticals; Fluorodeoxyglucose F18; Deoxyglucose
• Other Study ID Numbers: 2013/CHU/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No