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

Endometriosis Clinical Trial

— EndoSWI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186820
• Other study ID #: CHUBX 2017/03
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: April 24, 2018

Study information

• Verified date: November 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: April 24, 2018
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Disease Susceptibility
• Endometriosis

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (18)

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

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. — View Citation

Bazot M, Gasner A, Lafont C, Ballester M, Daraï 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. — View 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. — View Citation

Chapron C, Dubuisson JB. Management of deep endometriosis. Ann N Y Acad Sci. 2001 Sep;943:276-80. Review. — View 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. — View Citation

Fritzer N, Haas D, Oppelt P, Renner S, Hornung D, Wölfler 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. — View 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. Review. — View 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. — View Citation

Jarlot C, Anglade E, Paillocher N, Moreau D, Catala L, Aubé C. [MR imaging features of deep pelvic endometriosis: correlation with laparoscopy]. J Radiol. 2008 Nov;89(11 Pt 1):1745-54. French. — View 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. — View Citation

Olive DL, Schwartz LB. Endometriosis. N Engl J Med. 1993 Jun 17;328(24):1759-69. Review. — View 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. — View Citation

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

Solak A, Sahin N, Genç B, Sever AR, Genç 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. — View 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. — View 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Deep forms of endometriosis	MRI findings will be compared to surgical findings	Baseline (MRI) and day of surgery
Secondary	Superficial forms of endometriosis	MRI findings will be compared to surgical findings	Baseline (MRI) and day of surgery