Developing an US-MRI Biomarker Fusion Model for Endometriosis

Endometriosis Clinical Trial

— DEFEND  

Official title:

Developing an US-MRI Biomarker Fusion Model for Endometriosis (DEFEND)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974710
• Other study ID #: 20/WS/0111
• Status: Completed
• Start date: March 18, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2023
• Source: Perspectum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In the United Kingdom (UK), endometriosis is one of the most common gynaecological diseases needing treatment. The prevalence of disease is often underestimated, however it is believed to affect at least 1 in 10 women in the UK. Within the NHS, endometriosis costs the UK economy approximately £8.2 billion a year in treatment, loss of work and healthcare costs.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Previous surgery in 12 months prior to consent:

• abdominal surgery

• surgery for endometriosis

• The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).

• 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.

Related Conditions & MeSH terms

• Endometriosis
• Reproductive System Disorder

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
United Kingdom	King's Fertility	London

Sponsors (2)

Lead Sponsor	Collaborator
Perspectum	GE Healthcare

Country where clinical trial is conducted

United Kingdom, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assess the utility multi-parametric MRI in diagnosing and staging endometriosis	Using measurements such as cT1, PDFF and Diffusion Weighted Imaging (DWI) to the MR imaging variables with a clinical diagnosis.	12 months