Crohn DiseaseNCT06800326
Diagnostic Concordance of MR Enterography and Ultrasound for Treatment Response Assessment in Crohn's Disease (MANTRA)
An observational study of Crohn Disease, run by University College, London at 1 site in United Kingdom.
Trial summary
Crohn's disease is a lifelong condition resulting in inflammation of the bowel. Treatment with powerful drugs aim to reduce inflammation by suppressing the immune system. It is important to regularly assess if the drugs are effective, so they can be stopped or changed if not. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Ultrasound and MRE Scan
- How many people
- 155 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be male and female from 16 years and above who have small bowel or colonic Crohn's disease.
Who may be able to join
- Small bowel or colonic Crohn's disease
- 16 years or older
- Baseline/pre-treatment MR Enterography or Intestinal Ultrasound already performed as part of standard clinical care
- Follow up MR Enterography or Intestinal Ultrasound requested to assess treatment response within 15 months of baseline/ pre-treatment imaging
Who cannot join
- Interval resection of diseased segment(s)
- Inability to achieve informed consent
- Pregnancy
- Any contraindication/ intolerance to MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katerina Soteriou contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospitals
London
Michelle Berin, 0203456789, michelle.berin1@nhs.net
Maira Hameed
About this study
Official title: Diagnostic Concordance of MR Enterography and Ultrasound for Treatment Response Assessment in Crohn's Disease (MANTRA): a Multicentre, Non-randomised, Multiple-arm, Prospective Cohort Comparison Study
Crohn's disease is a lifelong condition resulting in inflammation of the bowel. Treatment with powerful drugs aim to reduce inflammation by suppressing the immune system. It is important to regularly assess if the drugs are effective, so they can be stopped or changed if not.
There are several ways doctors assess if the medication is effective as just relying on how the patient feels is not sufficient. Blood and stool tests looking for inflammation are useful but have limitations. Looking into the bowel using endoscopy is effective but very invasive. Medical imaging notably MR Enterography (MRE), a type of MRI scan, and intestinal ultrasound (IUS) visualise the bowel, and are safe, non-invasive and generally well tolerated tests frequently used in the NHS to assess how well treatment is working.
Read more
There is however wide variation in which imaging test is selected without clear guidance. The investigators currently do not know if one is better in assessing response to treatment, and if they can be used interchangeably.
The proposed study will investigate this question to guide the future care of Crohn's disease patients. The investigators will recruit patients having follow up imaging tests to assess their treatment and ask them to undergo both MRE and IUS. Radiologists will interpret the MRE and IUS, unaware of the findings of the other test, and state if the disease is improving or not. The doctors looking after the patient will then look at all available information e.g. symptoms, blood/stool tests, colonoscopy, and decide if the patient is the same, worse or better on the medication. This decision will be used to establish how accurate MRE and IUS are in assessing response, how often they agree and if they can be used interchangeably in the future, for example based on patient preference or availability at the hospital.
Read the detailed description
Imaging, typically with MR enterography (MRE) and/or Intestinal Ultrasound (IUS), is central in the follow up of Crohn's disease patients to assess treatment response to powerful immunosuppressive therapy. Practice varies widely on which imaging modality is selected and/or available and if they are used in isolation or interchangeably. There is currently no set guidance and practice varies widely.
We know that both MRE and IUS are accurate for diagnosing and staging Crohn's disease, although patients generally prefer IUS if it is of comparable accuracy. We however do not understand if MRE and IUS can be used interchangeably for treatment response assessment. Such uncertainty can impede patients and clinical teams in making informed management decisions.
Currently, IUS provision is sparse with no formal training programme, leading to a heavy bias for MRE. This approach is more costly, less tolerable to patients, adds pressure to already overloaded MRI workflows, and less environmentally sustainable. The current study may support the drive for comprehensive provision of both MRE and IUS services and training.
Currently, the literature is very limited and largely comprised of small single centre studies (most less than 50 patients), using inconsistent imaging definitions of treatment response, highly varied reference standards and differing follow up intervals. There are several MRE and IUS scores for objective disease assessment which remain to be fully validated for response and their respective agreement is not fully understood.
Ultimately, a major outstanding research question is not if investigators should use MRE or IUS, but rather, when investigators should use them in the management of individual patients. Accordingly, the European Society of Gastrointestinal and Abdominal Radiology (ESGAR) and the James Lind Alliance/Crohn's \& Colitis UK identify the current study topic as a key research priority.
The proposed prospective study will be the largest to date to investigate the accuracy of MRE and IUS for classification of treatment response against an expert consensus panel, their agreement in response assessment.
- Conditions
- Crohn Disease
- Being tested
- Ultrasound, MRE Scan
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Participants will have either an ultrasound or magnetic resonance imaging, depending on what scan they have had as part of their standard of care.
MRE ScanDiagnostic test
Participants will have either an ultrasound or magnetic resonance imaging, depending on what scan they have had as part of their standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Scan | An additional follow up IUS i.e. all participants undergo both a follow up MRE and IUS, with no participant randomisation. The cohort under US would have had an MRE as part of their standard of care. Receives: Diagnostic Test: Ultrasound; Diagnostic Test: MRE Scan | |
| MRE Scan | An additional follow up MRE i.e. all participants undergo both a follow up MRE and IUS, with no participant randomisation. The cohort under MRE would have had an IUS as part of their standard of care. Receives: Diagnostic Test: Ultrasound; Diagnostic Test: MRE Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The primary outcome will measure the difference in the percentage correct treatment response classification using MR Enterography (MRE) and Intestinal Ultrasound (IUS), against a multidisciplinary consensus panel reference standard.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start4 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Taylor, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800326
- Sponsor's protocol ID
- 172896
- Status last verified
- Jan 2025
- First submitted
- 29 Jul 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Radford SJ, Taylor S, Moran G. Ultrasound use to assess Crohn's disease in the UK: a survey of British Society of Gastroenterology Inflammatory Bowel Disease Group members. Frontline Gastroenterol. 2022 Jan 18;13(6):471-476. doi: 10.1136/flgastro-2021-102065. eCollection 2022.
PubMed 36250164Taylor SA, Mallett S, Bhatnagar G, Baldwin-Cleland R, Bloom S, Gupta A, Hamlin PJ, Hart AL, Higginson A, Jacobs I, McCartney S, Miles A, Murray CD, Plumb AA, Pollok RC, Punwani S, Quinn L, Rodriguez-Justo M, Shabir Z, Slater A, Tolan D, Travis S, Windsor A, Wylie P, Zealley I, Halligan S; METRIC study investigators. Diagnostic accuracy of magnetic resonance enterography and small bowel ultrasound for the extent and activity of newly diagnosed and relapsed Crohn's disease (METRIC): a multicentre trial. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):548-558. doi: 10.1016/S2468-1253(18)30161-4. Epub 2018 Jun 18.
PubMed 29914843Rimola J, Torres J, Kumar S, Taylor SA, Kucharzik T. Recent advances in clinical practice: advances in cross-sectional imaging in inflammatory bowel disease. Gut. 2022 Dec;71(12):2587-2597. doi: 10.1136/gutjnl-2021-326562. Epub 2022 Aug 4.
PubMed 35927032Novak KL, Nylund K, Maaser C, Petersen F, Kucharzik T, Lu C, Allocca M, Maconi G, de Voogd F, Christensen B, Vaughan R, Palmela C, Carter D, Wilkens R. Expert Consensus on Optimal Acquisition and Development of the International Bowel Ultrasound Segmental Activity Score [IBUS-SAS]: A Reliability and Inter-rater Variability Study on Intestinal Ultrasonography in Crohn's Disease. J Crohns Colitis. 2021 Apr 6;15(4):609-616. doi: 10.1093/ecco-jcc/jjaa216.
PubMed 33098642Hameed M, Adebusoye B, Mallett S, Soteriou K, De Kock I, Rafiee H, Halligan S, Taylor SA; MANTRA Study Collaborators. Diagnostic accuracy of magnetic resonance enterography and intestinal ultrasound for treatment response assessment in Crohn's disease (MANTRA): protocol for a multicentre, non-randomised, multiple-arm, prospective cohort comparison study. BMJ Open. 2026 Jul 27;16(7):e118654. doi: 10.1136/bmjopen-2026-118654.
PubMed 42509009
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Concordance of MR Enterography and Ultrasound for Treatment Response Assessment in Crohn's Disease (MANTRA): a Multicentre, Non-randomised, Multiple-arm, Prospective Cohort Comparison Study
- ClinicalTrials.gov ID
- NCT06800326
- Acronym / sponsor ID
- 172896
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 30 Jan 2025 (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.
Crohn's disease is a lifelong condition resulting in inflammation of the bowel. Treatment with powerful drugs aim to reduce inflammation by suppressing the immune system. It is important to regularly assess if the drugs are effective, so they can be stopped or changed if not.
There are several ways doctors assess if the medication is effective as just relying on how the patient feels is not sufficient. Blood and stool tests looking for inflammation are useful but have limitations. Looking into the bowel using endoscopy is effective but very invasive. Medical imaging notably MR Enterography (MRE), a type of MRI scan, and intestinal ultrasound (IUS) visualise the bowel, and are safe, non-invasive and generally well tolerated tests frequently used in the NHS to assess how well treatment is working.
There is however wide variation in which imaging test is selected without clear guidance. The investigators currently do not know if one is better in assessing response to treatment, and if they can be used interchangeably.
The proposed study will investigate this question to guide the future care of Crohn's disease patients. The investigators will recruit patients having follow up imaging tests to assess their treatment and ask them to undergo both MRE and IUS. Radiologists will interpret the MRE and IUS, unaware of the findings of the other test, and state if the disease is improving or not. The doctors looking after the patient will then look at all available information e.g. symptoms, blood/stool tests, colonoscopy, and decide if the patient is the same, worse or better on the medication. This decision will be used to establish how accurate MRE and IUS are in assessing response, how often they agree and if they can be used interchangeably in the future, for example based on patient preference or availability at the hospital.
Detailed description
Imaging, typically with MR enterography (MRE) and/or Intestinal Ultrasound (IUS), is central in the follow up of Crohn's disease patients to assess treatment response to powerful immunosuppressive therapy. Practice varies widely on which imaging modality is selected and/or available and if they are used in isolation or interchangeably. There is currently no set guidance and practice varies widely.
We know that both MRE and IUS are accurate for diagnosing and staging Crohn's disease, although patients generally prefer IUS if it is of comparable accuracy. We however do not understand if MRE and IUS can be used interchangeably for treatment response assessment. Such uncertainty can impede patients and clinical teams in making informed management decisions.
Currently, IUS provision is sparse with no formal training programme, leading to a heavy bias for MRE. This approach is more costly, less tolerable to patients, adds pressure to already overloaded MRI workflows, and less environmentally sustainable. The current study may support the drive for comprehensive provision of both MRE and IUS services and training.
Currently, the literature is very limited and largely comprised of small single centre studies (most less than 50 patients), using inconsistent imaging definitions of treatment response, highly varied reference standards and differing follow up intervals. There are several MRE and IUS scores for objective disease assessment which remain to be fully validated for response and their respective agreement is not fully understood.
Ultimately, a major outstanding research question is not if investigators should use MRE or IUS, but rather, when investigators should use them in the management of individual patients. Accordingly, the European Society of Gastrointestinal and Abdominal Radiology (ESGAR) and the James Lind Alliance/Crohn's \& Colitis UK identify the current study topic as a key research priority.
The proposed prospective study will be the largest to date to investigate the accuracy of MRE and IUS for classification of treatment response against an expert consensus panel, their agreement in response assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Scan | – | Diagnostic Test: Ultrasound, Diagnostic Test: MRE ScanAn additional follow up IUS i.e. all participants undergo both a follow up MRE and IUS, with no participant randomisation. The cohort under US would have had an MRE as part of their standard of care. |
| MRE Scan | – | Diagnostic Test: Ultrasound, Diagnostic Test: MRE ScanAn additional follow up MRE i.e. all participants undergo both a follow up MRE and IUS, with no participant randomisation. The cohort under MRE would have had an IUS as part of their standard of care. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be male and female from 16 years and above who have small bowel or colonic Crohn's disease.
Key inclusion criteria (4 listed)
- Small bowel or colonic Crohn's disease
- 16 years or older
- Baseline/pre-treatment MR Enterography or Intestinal Ultrasound already performed as part of standard clinical care
- Follow up MR Enterography or Intestinal Ultrasound requested to assess treatment response within 15 months of baseline/ pre-treatment imaging
Key exclusion criteria (4 listed)
- Interval resection of diseased segment(s)
- Inability to achieve informed consent
- Pregnancy
- Any contraindication/ intolerance to MRI
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 |
|---|---|---|
| UltrasoundParticipants will have either an ultrasound or magnetic resonance imaging, depending on what scan they have had as part of their standard of care. | Diagnostic test | MRE Scan, Ultrasound Scan |
| MRE ScanParticipants will have either an ultrasound or magnetic resonance imaging, depending on what scan they have had as part of their standard of care. | Diagnostic test | MRE Scan, Ultrasound Scan |
Primary outcome
Primary Outcome Measure
Time frame: 18 months
The primary outcome will measure the difference in the percentage correct treatment response classification using MR Enterography (MRE) and Intestinal Ultrasound (IUS), against a multidisciplinary consensus panel reference standard.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Results publication: PubMed 36250164Radford SJ, Taylor S, Moran G. Ultrasound use to assess Crohn's disease in the UK: a survey of British Society of Gastroenterology Inflammatory Bowel Disease Group members. Frontline Gastroenterol. 2022 Jan 18;13(6):471-476. doi: 10.1136/flgastro-2021-102065. eCollection 2022.
- Results publication: PubMed 29914843Taylor SA, Mallett S, Bhatnagar G, Baldwin-Cleland R, Bloom S, Gupta A, Hamlin PJ, Hart AL, Higginson A, Jacobs I, McCartney S, Miles A, Murray CD, Plumb AA, Pollok RC, Punwani S, Quinn L, Rodriguez-Justo M, Shabir Z, Slater A, Tolan D, Travis S, Windsor A, Wylie P, Zealley I, Halligan S; METRIC study investigators. Diagnostic accuracy of magnetic resonance enterography and small bowel ultrasound for the extent and activity of newly diagnosed and relapsed Crohn's disease (METRIC): a multicentre trial. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):548-558. doi: 10.1016/S2468-1253(18)30161-4. Epub 2018 Jun 18.
- Results publication: PubMed 35927032Rimola J, Torres J, Kumar S, Taylor SA, Kucharzik T. Recent advances in clinical practice: advances in cross-sectional imaging in inflammatory bowel disease. Gut. 2022 Dec;71(12):2587-2597. doi: 10.1136/gutjnl-2021-326562. Epub 2022 Aug 4.
- Results publication: PubMed 33098642Novak KL, Nylund K, Maaser C, Petersen F, Kucharzik T, Lu C, Allocca M, Maconi G, de Voogd F, Christensen B, Vaughan R, Palmela C, Carter D, Wilkens R. Expert Consensus on Optimal Acquisition and Development of the International Bowel Ultrasound Segmental Activity Score [IBUS-SAS]: A Reliability and Inter-rater Variability Study on Intestinal Ultrasonography in Crohn's Disease. J Crohns Colitis. 2021 Apr 6;15(4):609-616. doi: 10.1093/ecco-jcc/jjaa216.
- Derived from this study: PubMed 42509009Hameed M, Adebusoye B, Mallett S, Soteriou K, De Kock I, Rafiee H, Halligan S, Taylor SA; MANTRA Study Collaborators. Diagnostic accuracy of magnetic resonance enterography and intestinal ultrasound for treatment response assessment in Crohn's disease (MANTRA): protocol for a multicentre, non-randomised, multiple-arm, prospective cohort comparison study. BMJ Open. 2026 Jul 27;16(7):e118654. doi: 10.1136/bmjopen-2026-118654.
- Individual participant dataSharing planned: Undecided
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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.
Katerina Soteriou contact
Stuart Taylor principal investigator
University College London Hospitals
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 Crohn Disease, run by University College, London 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maira Hameed (020 7679 9274, maira.hameed@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 18 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 NCT06800326, which also lists 5 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 30 Jan 2025.