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

NCT06800326 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 155

Last updated 2025-01-30

No results posted yet for this study

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.

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.

Conditions

  • Crohn Disease

Interventions

DIAGNOSTIC_TEST

Ultrasound

Participants 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

Participants will have either an ultrasound or magnetic resonance imaging, depending on what scan they have had as part of their standard of care.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Stuart Taylor · UCLH

Eligibility

Min Age
16 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06800326 on ClinicalTrials.gov