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

Endometriosis Clinical Trial

— TEP-ENDORUN  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04831619
• Other study ID #: 2013/CHU/12
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Lucie AUZANNEAU
• Phone: (0)262 35 99 49
• Email: lucie.auzanneau[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 30, 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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).

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Réunion	Saint-Denis
France	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)