Developing an US-MRI Biomarker Fusion Model for Endometriosis
NCT ID: NCT04974710
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2022-03-18
2023-03-31
Brief Summary
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Detailed Description
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Currently, the first diagnostic recommendation for endometriosis is and Ultrasound (US) scan or a MRI, followed by a diagnostic surgery called laparoscopy. Accurate diagnoses is usually limited to specialist tertiary centres, therefore a delayed diagnosis is a significant problem for women with endometriosis. Limited experience in the disease area can also lead to misdiagnosis and the latest report from the National Institute of Clinical Excellence (NICE) reports a time delay of around 7.5 years before a confirmed diagnosis of endometriosis. A model that could accurately predict surgical findings of endometriosis would be of significant clinical and economical benefit.
The main aim of this study is to curate a database of patients with varying levels of endometriosis. This database will contain fully anonymised MR and US images alongside clinical data for further use in research. There will be no intervention outside of standard of care. US and clinical data will be collected during routine visits and patients will be offered an additional visit to have a MRI. The ultimate aim is to then use this data to develop a widely available diagnostic tool based on MRI and US imaging modalities using computer modelling. Validating the predictive model with surgical findings will increase confidence and access to advanced imaging for non-experts, allowing clinicians to accurately predict surgical findings as well as reduce time to diagnosis.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Outpatient MRI
All participants will undergo a standardised imaging protocol in a MRI scanner. This will take place during the same visit or following the transvaginal ultrasound (TVUS) and in advance of any surgical procedure (laparoscopy).
Eligibility Criteria
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Inclusion Criteria
* Clinically diagnosed endometriosis and awaiting surgery
* BMI 20-35 kg/m2
* No past abdominal surgical history
* Participant willing and able to give informed consent for participation in the study
Exclusion Criteria
* abdominal surgery
* surgery for endometriosis
* Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study.
18 Years
40 Years
FEMALE
No
Sponsors
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GE Healthcare
INDUSTRY
Perspectum
INDUSTRY
Responsible Party
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Principal Investigators
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Ippokratis Sarris, BM, BCh
Role: PRINCIPAL_INVESTIGATOR
King's Fertility
Locations
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King's Fertility
London, , United Kingdom
Countries
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References
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Bulun SE, Yilmaz BD, Sison C, Miyazaki K, Bernardi L, Liu S, Kohlmeier A, Yin P, Milad M, Wei J. Endometriosis. Endocr Rev. 2019 Aug 1;40(4):1048-1079. doi: 10.1210/er.2018-00242.
Bondza PK, Maheux R, Akoum A. Insights into endometriosis-associated endometrial dysfunctions: a review. Front Biosci (Elite Ed). 2009 Jun 1;1(2):415-28. doi: 10.2741/E38.
Johnson NP, Hummelshoj L, Adamson GD, Keckstein J, Taylor HS, Abrao MS, Bush D, Kiesel L, Tamimi R, Sharpe-Timms KL, Rombauts L, Giudice LC; World Endometriosis Society Sao Paulo Consortium. World Endometriosis Society consensus on the classification of endometriosis. Hum Reprod. 2017 Feb;32(2):315-324. doi: 10.1093/humrep/dew293. Epub 2016 Dec 5.
Heilier JF, Donnez J, Nackers F, Rousseau R, Verougstraete V, Rosenkranz K, Donnez O, Grandjean F, Lison D, Tonglet R. Environmental and host-associated risk factors in endometriosis and deep endometriotic nodules: a matched case-control study. Environ Res. 2007 Jan;103(1):121-9. doi: 10.1016/j.envres.2006.04.004. Epub 2006 Jun 15.
Koninckx PR, Martin DC. Deep endometriosis: a consequence of infiltration or retraction or possibly adenomyosis externa? Fertil Steril. 1992 Nov;58(5):924-8. doi: 10.1016/s0015-0282(16)55436-3.
Ferrero S, Alessandri F, Racca A, Leone Roberti Maggiore U. Treatment of pain associated with deep endometriosis: alternatives and evidence. Fertil Steril. 2015 Oct;104(4):771-792. doi: 10.1016/j.fertnstert.2015.08.031. Epub 2015 Sep 10.
Leyland N, Casper R, Laberge P, Singh SS; SOGC. Endometriosis: diagnosis and management. J Obstet Gynaecol Can. 2010 Jul;32(7 Suppl 2):S1-32.
Berger J, Henneman O, Rhemrev J, Smeets M, Jansen FW. MRI-Ultrasound Fusion Imaging for Diagnosis of Deep Infiltrating Endometriosis - A Critical Appraisal. Ultrasound Int Open. 2018 Sep;4(3):E85-E90. doi: 10.1055/a-0647-1575. Epub 2018 Sep 24.
Bazot M, Thomassin I, Hourani R, Cortez A, Darai E. Diagnostic accuracy of transvaginal sonography for deep pelvic endometriosis. Ultrasound Obstet Gynecol. 2004 Aug;24(2):180-5. doi: 10.1002/uog.1108.
Slack A, Child T, Lindsey I, Kennedy S, Cunningham C, Mortensen N, Koninckx P, McVeigh E. Urological and colorectal complications following surgery for rectovaginal endometriosis. BJOG. 2007 Oct;114(10):1278-82. doi: 10.1111/j.1471-0528.2007.01477.x.
Padavala J, Navaneetham N. Complications after surgery for deeply infiltrating pelvic endometriosis. BJOG. 2011 Dec;118(13):1678; author reply 1678-9. doi: 10.1111/j.1471-0528.2011.03162.x. No abstract available.
Nezhat C, Li A, Falik R, Copeland D, Razavi G, Shakib A, Mihailide C, Bamford H, DiFrancesco L, Tazuke S, Ghanouni P, Rivas H, Nezhat A, Nezhat C, Nezhat F. Bowel endometriosis: diagnosis and management. Am J Obstet Gynecol. 2018 Jun;218(6):549-562. doi: 10.1016/j.ajog.2017.09.023. Epub 2017 Oct 13.
Rosefort A, Huchon C, Estrade S, Paternostre A, Bernard JP, Fauconnier A. Is training sufficient for ultrasound operators to diagnose deep infiltrating endometriosis and bowel involvement by transvaginal ultrasound? J Gynecol Obstet Hum Reprod. 2019 Feb;48(2):109-114. doi: 10.1016/j.jogoh.2018.04.004. Epub 2018 Apr 11.
Creed JM, Maggrah A, Usher R, Desa E, Harbottle A. How can mitochondrial DNA deletions act as a biomarker for the detection of endometriosis within the clinic? Biomark Med. 2020 Jan;14(1):5-8. doi: 10.2217/bmm-2019-0435. Epub 2019 Nov 5. No abstract available.
Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
Other Identifiers
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20/WS/0111
Identifier Type: -
Identifier Source: org_study_id