Developing an US-MRI Biomarker Fusion Model for Endometriosis

NCT04974710 | Completed

• 1 other identifier: 20/WS/0111
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Single centre, prospective, observational, cohort study looking to develop a database representing the variability of disease and imaging seen in women with clinically diagnosed endometriosis, awaiting laparoscopic surgery.

Conditions

Endometriosis; Reproductive System Disorder

Keywords

Reproductive health; Diagnostics; Magnetic Resonance Imaging; Ultrasound; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Build a database of 100 patients with endometriosis, awaiting confirmatory laparoscopic surgery on to an anonymised database for future use in algorithm development.

  12 months

Secondary Outcomes (2)

• Evaluate inter-observer variability in diagnosing and staging endometriosis using both two and three dimensional ultrasound by computing inter-rater agreement statistics (e.g. Kappa statistic)

  12 months

• Assess the utility multi-parametric MRI in diagnosing and staging endometriosis

  12 months

Interventions

Outpatient MRI DIAGNOSTIC_TEST

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

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with clinically diagnosed endometriosis and awaiting laparoscopic surgery

You may qualify if:

• Women aged between 18-40 years
• 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

You may not qualify if:

• Previous surgery in 12 months prior to consent:
• 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.

Sponsors & Collaborators

• Perspectum: lead
• GE Healthcare: collaborator

Study Sites (1)

King's Fertility

London, SE5 8BB, United Kingdom

Location

Related Publications (15)

• 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.

  PMID: 30994890 BACKGROUND

• 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.

  PMID: 19482656 BACKGROUND

• 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.

  PMID: 27920089 BACKGROUND

• 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.

  PMID: 16781705 BACKGROUND

• 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.

  PMID: 1426377 BACKGROUND

• 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.

  PMID: 26363387 BACKGROUND

• 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.

  PMID: 21545757 BACKGROUND

• 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.

  PMID: 30255164 BACKGROUND

• 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.

  PMID: 15287057 BACKGROUND

• 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.

  PMID: 17877680 BACKGROUND

• 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.

  PMID: 22077260 BACKGROUND

• 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.

  PMID: 29032051 BACKGROUND

• 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.

  PMID: 29654939 BACKGROUND

• 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.

  PMID: 31686548 BACKGROUND

• Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.

  PMID: 15883903 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 Officials

• Ippokratis Sarris, BM, BCh

  King's Fertility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 23, 2021
• Study Start: March 18, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)