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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 24, 2018

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.

Interventions

  • Other: Susceptibility Weighted Imaging as 3D SWAN sequence
    • Susceptibility Weighted Imaging as 3D SWAN sequence

Arms, Groups and Cohorts

  • Experimental: SWAN sequence
    • Susceptibility Weighted Imaging as 3D SWAN sequence

Clinical Trial Outcome Measures

Primary Measures

  • Interest of MRI Susceptibility Weighted Imaging
    • Time Frame: 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 Measures

  • Deep forms of endometriosis
    • Time Frame: Baseline (MRI) and day of surgery
    • MRI findings will be compared to surgical findings
  • Superficial forms of endometriosis
    • Time Frame: Baseline (MRI) and day of surgery
    • MRI findings will be compared to surgical findings

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Bordeaux
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

Olive DL, Schwartz LB. Endometriosis. N Engl J Med. 1993 Jun 17;328(24):1759-69. doi: 10.1056/NEJM199306173282407. No abstract available.

Siegelman et al." Radiographics: A Review Publication of the Radiological Society of North America, Inc 32, no. 6 (October 2012).

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.

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.

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.

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.

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

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.

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.

Siegelman ES, Oliver ER. MR imaging of endometriosis: ten imaging pearls. Radiographics. 2012 Oct;32(6):1675-91. doi: 10.1148/rg.326125518.

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.

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.

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.

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.

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.

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.

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.

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.

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