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

Sponsor

Centre Hospitalier Universitaire de la Réunion (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04831619

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Drug: PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire Réunion	Saint-Denis		France	97400
2	CHU de la Réunion	Saint-Pierre		France	97448

Sponsors and Collaborators

Centre Hospitalier Universitaire de la Réunion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de la Réunion

ClinicalTrials.gov Identifier:

NCT04831619

Other Study ID Numbers:

2013/CHU/12

First Posted:

Apr 5, 2021

Last Update Posted:

Mar 2, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometriosis

Deoxyglucose

Fluorodeoxyglucose F18

Study Results

No Results Posted as of Mar 2, 2022