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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET scanner in addition to MRI<br> | Drug: PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)<br>* A PET scan will be performed in the patients included, in addition to the conventional imaging workup (MRI, endovaginal and pelvic ultrasound).<br>|

What is the study measuring?
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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) |