2024-520423-88-00
Not yet recruiting
Phase 3
Contribution of PET (positron emission tomography) scans for the preoperative assessment of symptomatic endometriosis lesions: TEP-ENDORUN
Centre Hospitalier Universitaire De La Reunion1 site in 1 country15 target enrollmentStarted: January 29, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Centre Hospitalier Universitaire De La Reunion
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Total number of endometriosis lesions diagnosed by PET scan in our 10 patients compared with the number of lesions described during surgery.
Overview
Brief Summary
To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient aged over 18 and under 50
- •Patient with symptomatic endometriosis with indication for surgery
- •Patient showing at least one typical endometriosis lesion on MRI, greater than 5mm
- •Patient accepting surgical management
- •Patient having signed an informed consent after information
- •Patient 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)
- •Use of corticosteroids and anti-inflammatory drugs within 7 days prior to PET scan For patients with a chronic pathology requiring long-term treatment with corticosteroids and/or use of corticosteroids and anti-inflammatory drugs within 7 days prior to PET scan
- •Blood glucose > 1.6 g/L e on day of PET Scanner
- •Patient with a history of heavy abdominopelvic surgery
- •Diabetic patient
- •Patient with contraindication to surgery or anesthesia
- •Patient unable to understand the interest of the study
- •Patient with 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.)
- •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)
Outcomes
Primary Outcomes
Total number of endometriosis lesions diagnosed by PET scan in our 10 patients compared with the number of lesions described during surgery.
Total number of endometriosis lesions diagnosed by PET scan in our 10 patients compared with the number of lesions described during surgery.
Number of locations identified by PET scan compared with number of locations identified during surgery.
Number of locations identified by PET scan compared with number of locations identified during surgery.
Secondary Outcomes
- SUV threshold to identify endometriosis lesions.
- Number of lesions visible on PET scan and not visible on MRI, location on PET scan compared with MRI
Investigators
TRAN
Scientific
Centre Hospitalier Universitaire De La Reunion
Study Sites (1)
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