Exploratory Study of the Interest of MRI Susceptibility Weighted Imaging for the Pre-operative Assessment of Pelvic Endometriosis Extent

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Other: Susceptibility Weighted Imaging as 3D SWAN sequence

• Registration Number: NCT03186820
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Knowledge of the precise location of endometriosis is essential for a successful surgical treatment. MRI Susceptibility-Weighted Imaging (SWI-MRI) yields high sensitivity for blood by-products detection. Since endometriosis lesions are haemorrhagic, and therefore rich in blood by-products such as hemosiderin, SWI-MRI could be useful in the pre-operative assessment of endometriosis, especially in superficial peritoneal lesion detection. The purpose of our study is to evaluate the performance of SWI-MRI for the preoperative work-up of endometriosis

Detailed Description

Pelvic endometriosis is a cause of pelvic pain, dysmenorrhea, urinary symptoms and infertility. MRI is considered as the best imaging technique to detect and to predict the extent of the disease. Susceptibility Weighted Imaging is routinely performed to identify haemorrhagic lesions in brain MRI protocols and has proven to be a sensitive technique to detect blood by-products. A pelvic MRI protocol including SWI will be performed in all women addressed for diagnostic assessment or pre-operative work-up of endometriosis.

Study Timeline

• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-14
• Study Start: 2017-06-19
• Primary Completion: 2018-04-24
• Study Completion: 2018-04-24
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-08
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

• Adult woman (over 18yrs old) addressed for diagnostic assessment or pre-operative work-up of endometriosis;
• Informed signed consent
• Affiliated or beneficiary of a social security system

Exclusion Criteria

• Patient <18yrs old
• Pregnant or nursing woman
• Patient under legal protection
• Contraindication to MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SWAN sequence	Susceptibility Weighted Imaging as 3D SWAN sequence	Susceptibility Weighted Imaging as 3D SWAN sequence

Primary Outcome Measures

Name	Time	Method
Interest of MRI Susceptibility Weighted Imaging	Baseline (MRI) and day of surgery	The diagnostic use of SWI-MRI will be assessed through: * the number of endometriotic locations, which are both identified with SWI-MRI and confirmed by surgery.; * the sensitivity, specificity, and predictive values of MRI.; * signal intensities of each endometriotic location found in surgery on T1 weighted sequence (presence of a high signal intensity) and SWI (presence of a low signal intensity)

Secondary Outcome Measures

Name	Time	Method
Deep forms of endometriosis	Baseline (MRI) and day of surgery	MRI findings will be compared to surgical findings
Superficial forms of endometriosis	Baseline (MRI) and day of surgery	MRI findings will be compared to surgical findings

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France