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

NCT03186820 | Completed

• 1 other identifier: CHUBX 2017/03
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Endometriosis

Keywords

Endometriosis; Magnetic resonance imaging (MRI); Susceptibility-weighted imaging (SWI)

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline (MRI) and day of surgery

Secondary Outcomes (2)

• Deep forms of endometriosis

  Baseline (MRI) and day of surgery

• Superficial forms of endometriosis

  Baseline (MRI) and day of surgery

Study Arms (1)

SWAN sequence

EXPERIMENTAL

Susceptibility Weighted Imaging as 3D SWAN sequence

Other: Susceptibility Weighted Imaging as 3D SWAN sequence

Interventions

Susceptibility Weighted Imaging as 3D SWAN sequence OTHER

Susceptibility Weighted Imaging as 3D SWAN sequence

SWAN sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (19)

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

  BACKGROUND

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  BACKGROUND

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  PMID: 23065164 BACKGROUND

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  PMID: 8037030 BACKGROUND

• 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.

  PMID: 19039041 BACKGROUND

• 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.

  PMID: 20858832 BACKGROUND

• 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.

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• 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.

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  PMID: 18941070 BACKGROUND

• 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.

  PMID: 23763857 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective monocentric comparative study

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 14, 2017
• Study Start: June 19, 2017
• Primary Completion: April 24, 2018
• Study Completion: April 24, 2018
• Last Updated: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)