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

May 27, 2026 updated by: Perspectum

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with clinically diagnosed endometriosis and awaiting laparoscopic surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Build a database of 100 patients with endometriosis, awaiting confirmatory laparoscopic surgery on to an anonymised database for future use in algorithm development.
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perspectum

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Ippokratis Sarris, BM, BCh, King's Fertility

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/WS/0111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant will be identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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