Exploratory Study of the Interest of MRI Susceptibility Weighted Imaging for the Pre-operative Assessment of Pelvic Endometriosis Extent (EndoSWI)
Primary Purpose
Endometriosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Susceptibility Weighted Imaging as 3D SWAN sequence
Sponsored by
About this trial
This is an interventional prevention trial for Endometriosis focused on measuring Endometriosis, Magnetic resonance imaging (MRI), Susceptibility-weighted imaging (SWI)
Eligibility Criteria
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
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SWAN sequence
Arm Description
Susceptibility Weighted Imaging as 3D SWAN sequence
Outcomes
Primary Outcome Measures
Interest of MRI Susceptibility Weighted Imaging
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
Deep forms of endometriosis
MRI findings will be compared to surgical findings
Superficial forms of endometriosis
MRI findings will be compared to surgical findings
Full Information
NCT ID
NCT03186820
First Posted
June 2, 2017
Last Updated
November 8, 2018
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT03186820
Brief Title
Exploratory Study of the Interest of MRI Susceptibility Weighted Imaging for the Pre-operative Assessment of Pelvic Endometriosis Extent
Acronym
EndoSWI
Official Title
Exploratory Study of the Interest of MRI Susceptibility Weighted Imaging for the Pre-operative Assessment of Pelvic Endometriosis Extent
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
April 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, Magnetic resonance imaging (MRI), Susceptibility-weighted imaging (SWI)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective monocentric comparative study
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SWAN sequence
Arm Type
Experimental
Arm Description
Susceptibility Weighted Imaging as 3D SWAN sequence
Intervention Type
Other
Intervention Name(s)
Susceptibility Weighted Imaging as 3D SWAN sequence
Intervention Description
Susceptibility Weighted Imaging as 3D SWAN sequence
Primary Outcome Measure Information:
Title
Interest of MRI Susceptibility Weighted Imaging
Description
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)
Time Frame
Baseline (MRI) and day of surgery
Secondary Outcome Measure Information:
Title
Deep forms of endometriosis
Description
MRI findings will be compared to surgical findings
Time Frame
Baseline (MRI) and day of surgery
Title
Superficial forms of endometriosis
Description
MRI findings will be compared to surgical findings
Time Frame
Baseline (MRI) and day of surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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27632570
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Exploratory Study of the Interest of MRI Susceptibility Weighted Imaging for the Pre-operative Assessment of Pelvic Endometriosis Extent
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