search
Back to results

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
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
June 2, 2017
Last Updated
November 8, 2018
Sponsor
University Hospital, Bordeaux
search

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:
PubMed Identifier
27632570
Citation
Saha R, Kuja-Halkola R, Tornvall P, Marions L. Reproductive and Lifestyle Factors Associated with Endometriosis in a Large Cross-Sectional Population Sample. J Womens Health (Larchmt). 2017 Feb;26(2):152-158. doi: 10.1089/jwh.2016.5795. Epub 2016 Sep 15.
Results Reference
background
PubMed Identifier
8110213
Citation
Olive DL, Schwartz LB. Endometriosis. N Engl J Med. 1993 Jun 17;328(24):1759-69. doi: 10.1056/NEJM199306173282407. No abstract available.
Results Reference
background
Citation
Siegelman et al." Radiographics: A Review Publication of the Radiological Society of North America, Inc 32, no. 6 (October 2012).
Results Reference
background
PubMed Identifier
23642970
Citation
Fritzer N, Haas D, Oppelt P, Renner S, Hornung D, Wolfler M, Ulrich U, Fischerlehner G, Sillem M, Hudelist G. More than just bad sex: sexual dysfunction and distress in patients with endometriosis. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):392-6. doi: 10.1016/j.ejogrb.2013.04.001. Epub 2013 May 1.
Results Reference
background
PubMed Identifier
11594547
Citation
Chapron C, Dubuisson JB. Management of deep endometriosis. Ann N Y Acad Sci. 2001 Sep;943:276-80. doi: 10.1111/j.1749-6632.2001.tb03808.x.
Results Reference
background
PubMed Identifier
22441923
Citation
Benacerraf BR, Groszmann Y. Sonography should be the first imaging examination done to evaluate patients with suspected endometriosis. J Ultrasound Med. 2012 Apr;31(4):651-3. doi: 10.7863/jum.2012.31.4.651. No abstract available.
Results Reference
background
PubMed Identifier
24165087
Citation
Holland TK, Cutner A, Saridogan E, Mavrelos D, Pateman K, Jurkovic D. Ultrasound mapping of pelvic endometriosis: does the location and number of lesions affect the diagnostic accuracy? A multicentre diagnostic accuracy study. BMC Womens Health. 2013 Oct 29;13:43. doi: 10.1186/1472-6874-13-43.
Results Reference
background
Citation
Abrao et al. "Comparison between Clinical Examination, Transvaginal Sonography and Magnetic Resonance Imaging for the Diagnosis of Deep Endometriosis." Human Reproduction (Oxford, England) 22, no. 12 (December 2007). Bazot et al. "Diagnostic Accuracy of Physical Examination, Transvaginal Sonography, Rectal Endoscopic Sonography, and Magnetic Resonance Imaging to Diagnose Deep Infiltrating Endometriosis." Fertility and Sterility 92, no. 6 (December 2009). Bazot, M., N. Bharwani, C. Huchon, K. Kinkel, T. M. Cunha, A. Guerra, L. Manganaro, et al. "European Society of Urogenital Radiology (ESUR) Guidelines: MR Imaging of Pelvic Endometriosis." European Radiology, December 5, 2016
Results Reference
background
PubMed Identifier
19106831
Citation
Jarlot C, Anglade E, Paillocher N, Moreau D, Catala L, Aube C. [MR imaging features of deep pelvic endometriosis: correlation with laparoscopy]. J Radiol. 2008 Nov;89(11 Pt 1):1745-54. doi: 10.1016/s0221-0363(08)74479-2. French.
Results Reference
background
PubMed Identifier
21216125
Citation
Bazot M, Gasner A, Lafont C, Ballester M, Darai E. Deep pelvic endometriosis: limited additional diagnostic value of postcontrast in comparison with conventional MR images. Eur J Radiol. 2011 Dec;80(3):e331-9. doi: 10.1016/j.ejrad.2010.12.006. Epub 2011 Jan 7.
Results Reference
background
PubMed Identifier
23065164
Citation
Siegelman ES, Oliver ER. MR imaging of endometriosis: ten imaging pearls. Radiographics. 2012 Oct;32(6):1675-91. doi: 10.1148/rg.326125518.
Results Reference
background
PubMed Identifier
8037030
Citation
Siegelman ES, Outwater E, Wang T, Mitchell DG. Solid pelvic masses caused by endometriosis: MR imaging features. AJR Am J Roentgenol. 1994 Aug;163(2):357-61. doi: 10.2214/ajr.163.2.8037030.
Results Reference
background
PubMed Identifier
19039041
Citation
Haacke EM, Mittal S, Wu Z, Neelavalli J, Cheng YC. Susceptibility-weighted imaging: technical aspects and clinical applications, part 1. AJNR Am J Neuroradiol. 2009 Jan;30(1):19-30. doi: 10.3174/ajnr.A1400. Epub 2008 Nov 27.
Results Reference
background
PubMed Identifier
20858832
Citation
Nair JR, Van Hecke W, De Belder F, Venstermans C, van den Hauwe L, Van Goethem J, Parizel PM. High-resolution susceptibility-weighted imaging at 3 T with a 32-channel head coil: technique and clinical applications. AJR Am J Roentgenol. 2010 Oct;195(4):1007-14. doi: 10.2214/AJR.10.4218.
Results Reference
background
PubMed Identifier
23308170
Citation
Bai Y, Wang MY, Han YH, Dou SW, Lin Q, Guo Y, Li W, Ding DG, Dai JP, Qin W, Shi DP, Tian J, Dai YM. Susceptibility weighted imaging: a new tool in the diagnosis of prostate cancer and detection of prostatic calcification. PLoS One. 2013;8(1):e53237. doi: 10.1371/journal.pone.0053237. Epub 2013 Jan 7.
Results Reference
background
PubMed Identifier
26315838
Citation
Cimsit C, Yoldemir T, Guclu M, Akpinar IN. Susceptibility-weighted magnetic resonance imaging for the evaluation of deep infiltrating endometriosis: preliminary results. Acta Radiol. 2016 Jul;57(7):878-85. doi: 10.1177/0284185115602147. Epub 2015 Aug 27.
Results Reference
background
PubMed Identifier
25682291
Citation
Takeuchi M, Matsuzaki K, Harada M. Susceptibility-weighted MRI of extra-ovarian endometriosis: preliminary results. Abdom Imaging. 2015 Oct;40(7):2512-6. doi: 10.1007/s00261-015-0378-z.
Results Reference
background
PubMed Identifier
18941070
Citation
Takeuchi M, Matsuzaki K, Nishitani H. Susceptibility-weighted MRI of endometrioma: preliminary results. AJR Am J Roentgenol. 2008 Nov;191(5):1366-70. doi: 10.2214/AJR.07.3974.
Results Reference
background
PubMed Identifier
23763857
Citation
Solak A, Sahin N, Genc B, Sever AR, Genc M, Sivrikoz ON. Diagnostic value of susceptibility-weighted imaging of abdominal wall endometriomas during the cyclic menstrual changes: a preliminary study. Eur J Radiol. 2013 Sep;82(9):e411-6. doi: 10.1016/j.ejrad.2013.04.030. Epub 2013 Jun 10.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs