Clinical trial NCT04974710: Developing an US-MRI Biomarker Fusion Model for Endometriosis
Official title: Developing an US-MRI Biomarker Fusion Model for Endometriosis (DEFEND)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Reproductive System Disorder
Keywords: Reproductive health
Diagnostics
Magnetic Resonance Imaging
Ultrasound
Biomarkers
Lead sponsor: Perspectum
Sponsor class: INDUSTRY
Collaborators: name: GE Healthcare
First posted: 2021-07-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with clinically diagnosed endometriosis and awaiting laparoscopic surgery

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Build a database of 100 patients with endometriosis, awaiting confirmatory laparoscopic surgery on to an anonymised database for future use in algorithm development.
timeFrame: 12 months
Secondary outcomes:
measure: 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)
timeFrame: 12 months
measure: Assess the utility multi-parametric MRI in diagnosing and staging endometriosis
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's Fertility
Study officials:
affiliation: King's Fertility
name: Ippokratis Sarris, BM, BCh
role: PRINCIPAL_INVESTIGATOR
References:
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