Clinical trial NCT04831619: Contribution of PET (Positron Emission Tomography) Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN
Official title: Contribution of PET Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endometriosis
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.
timeFrame: at inclusion (before surgery)
Secondary outcomes:
measure: Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions
timeFrame: up to 14 weeks (after surgery)
measure: Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions
timeFrame: up to 14 weeks (after surgery)
measure: Define a reading threshold of SUV (Standardized Uptake Value) on a PET scanner for the diagnosis of endometriosis
timeFrame: up to 14 weeks (after PET-Scanner)
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Centre Hospitalier Universitaire Réunion
city: Saint-Pierre
country: France
facility: CHU de la Réunion
Study officials:
References: