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

NCT06800326 | Recruiting

• 1 other identifier: 172896
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Study Arms (2)

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.

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.

Diagnostic Test: Ultrasound; Diagnostic Test: MRE Scan

Interventions

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; Ultrasound Scan

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.

MRE Scan; Ultrasound Scan

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be male and female from 16 years and above who have small bowel or colonic Crohn's disease.

You may qualify if:

• Small bowel or colonic Crohn's disease
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospitals

London, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 36250164 RESULT

• Taylor 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.

  PMID: 29914843 RESULT

• Rimola 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.

  PMID: 35927032 RESULT

• Novak 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.

  PMID: 33098642 RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stuart Taylor

  UCLH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maira Hameed

CONTACT

020 7679 9274; maira.hameed@ucl.ac.uk

Katerina Soteriou

CONTACT

katerina.soteriou@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: January 30, 2025
• Study Start: October 4, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

GB (1)