EndometriosisDEFENDNCT04974710
Developing an US-MRI Biomarker Fusion Model for Endometriosis
An observational study of Endometriosis and Reproductive System Disorder, run by Perspectum at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis, Reproductive System Disorder
- What is being tested?
- Outpatient MRI
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Mar 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with clinically diagnosed endometriosis and awaiting laparoscopic surgery
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis, Reproductive System Disorder
- Being tested
- Outpatient MRI
- Keywords
- Reproductive health, Diagnostics, Magnetic Resonance Imaging, Ultrasound, Biomarkers
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient MRIDiagnostic 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Build a database of 100 patients with endometriosis, awaiting confirmatory laparoscopic surgery on to an anonymised database for future use in algorithm development.
Measured: 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)
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start18 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Ippokratis Sarris, BM, BCh, Principal investigator, King's Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974710
- Sponsor's protocol ID
- 20/WS/0111
- Acronym
- DEFEND
- Status last verified
- May 2026
- First submitted
- 11 Jun 2021
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant will be identified.
Publications
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.
PubMed 30994890Bondza 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.
PubMed 19482656Johnson 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.
PubMed 27920089Heilier 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.
PubMed 16781705Koninckx 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.
PubMed 1426377Ferrero 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.
PubMed 26363387Leyland N, Casper R, Laberge P, Singh SS; SOGC. Endometriosis: diagnosis and management. J Obstet Gynaecol Can. 2010 Jul;32(7 Suppl 2):S1-32.
PubMed 21545757Berger 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.
PubMed 30255164Bazot 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.
PubMed 15287057Slack 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.
PubMed 17877680Padavala 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.
PubMed 22077260Nezhat 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.
PubMed 29032051Rosefort 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.
PubMed 29654939Creed 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.
PubMed 31686548Viera AJ, Garrett JM. Understanding interobserver agreement: the kappa statistic. Fam Med. 2005 May;37(5):360-3.
PubMed 15883903
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an US-MRI Biomarker Fusion Model for Endometriosis (DEFEND)
- ClinicalTrials.gov ID
- NCT04974710
- Acronym / sponsor ID
- DEFEND / 20/WS/0111
- Conditions
- Endometriosis, Reproductive System Disorder
- Keywords
- Reproductive health, Diagnostics, Magnetic Resonance Imaging, Ultrasound, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Collaborators
- GE Healthcare
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with clinically diagnosed endometriosis and awaiting laparoscopic surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Previous surgery in 12 months prior to consent:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient MRIAll 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). | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
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
Assess the utility multi-parametric MRI in diagnosing and staging endometriosis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 30994890Bulun 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.
- Background: PubMed 19482656Bondza 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.
- Background: PubMed 27920089Johnson 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.
- Background: PubMed 16781705Heilier 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.
- Background: PubMed 1426377Koninckx 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.
- Background: PubMed 26363387Ferrero 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.
- Background: PubMed 21545757Leyland N, Casper R, Laberge P, Singh SS; SOGC. Endometriosis: diagnosis and management. J Obstet Gynaecol Can. 2010 Jul;32(7 Suppl 2):S1-32.
- Background: PubMed 30255164Berger 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.
- Background: PubMed 15287057Bazot 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.
- Background: PubMed 17877680Slack 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.
- Background: PubMed 22077260Padavala 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.
- Background: PubMed 29032051Nezhat 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.
- Individual participant dataSharing planned: No. No individual participant will be identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ippokratis Sarris, BM, BCh principal investigator
King's Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Reproductive System Disorder, run by Perspectum at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04974710, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.