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NCT Number: NCT06800326

Diagnostic Concordance of MR Enterography and Ultrasound for Treatment Response Assessment in Crohn's Disease (MANTRA)

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University College London Hospitals

London, United Kingdom

Location status: Recruiting

Location contact

Maira Hameed

PRINCIPAL_INVESTIGATOR

Michelle Berin

CONTACT

[email protected]

0203456789

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Interval resection of diseased segment(s)
  • Inability to achieve informed consent
  • Pregnancy
  • Any contraindication/ intolerance to MRI

Treatment and study plan

Ultrasound

Diagnostic 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 Scan

Diagnostic 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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katerina Soteriou

CONTACT

[email protected]

Maira Hameed

CONTACT

[email protected]

020 7679 9274

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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