AzTrials
AzTrials

EndometriosisEndoSWINCT03186820

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

A study testing Susceptibility Weighted Imaging as 3D SWAN sequence in people with Endometriosis, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometriosis
What is being tested?
Susceptibility Weighted Imaging as 3D SWAN sequence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteFrance
Study dates
19 Jun 2017to 24 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Bordeaux

    Bordeaux, 33076

Other trials in France

About this study

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

Read the 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.

Conditions
Endometriosis
Being tested
Susceptibility Weighted Imaging as 3D SWAN sequence
Keywords
Endometriosis, Magnetic resonance imaging (MRI), Susceptibility-weighted imaging (SWI)
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Susceptibility Weighted Imaging as 3D SWAN sequenceOther

    Susceptibility Weighted Imaging as 3D SWAN sequence

Study groups in NCT03186820
Study groupRoleWhat they receive
SWAN sequenceExperimentalSusceptibility Weighted Imaging as 3D SWAN sequence
Receives: Other: Susceptibility Weighted Imaging as 3D SWAN sequence

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline (MRI) and day of surgery

Secondary outcomes (2)

  1. Deep forms of endometriosis

    MRI findings will be compared to surgical findings

    Measured: Baseline (MRI) and day of surgery

  2. Superficial forms of endometriosis

    MRI findings will be compared to surgical findings

    Measured: Baseline (MRI) and day of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2017
  2. Study start19 Jun 2017
  3. Primary completion24 Apr 2018
  4. Study completion24 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective monocentric comparative study
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03186820
Sponsor's protocol ID
CHUBX 2017/03
Other IDs
2017-A00698-45
Acronym
EndoSWI
Status last verified
Nov 2018
First submitted
2 Jun 2017
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27632570

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

    PubMed 8110213

  • 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.

    PubMed 23642970

  • 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.

    PubMed 11594547

  • 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.

    PubMed 22441923

  • 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.

    PubMed 24165087

  • 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.

    PubMed 19106831

  • 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.

    PubMed 21216125

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

    PubMed 23065164

  • 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.

    PubMed 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.

    PubMed 19039041

  • 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.

    PubMed 20858832

  • 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.

    PubMed 23308170

Questions about this trial

What is this clinical trial studying?

A study testing Susceptibility Weighted Imaging as 3D SWAN sequence in people with Endometriosis, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interest of MRI Susceptibility Weighted Imaging (time frame: Baseline (MRI) and day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03186820, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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