Using imaging to improve the prediction of disabling Crohn's Disease

Magnetic resonance enterography as a predictor of disabling disease in newly diagnosed Crohn's Disease

Registry ID
ISRCTN76899103
Source registry
ISRCTN
Status
No longer recruiting
Study type
OBSERVATIONAL
Sponsor
University College London
Enrollment
207
Start date
2019-03-25
Completion date
2022-12-31
Last update
2026-08-17

Conditions

Summary

Crohn’s disease

Detailed description

The study aims to determine if abnormalities in MRE and SBUS at diagnosis can predict which patients are destined to develop severe (“disabling”) Crohn’s disease, defined using existing definitions from the literature. Patients will have had more than 4 years of follow up since they were initially diagnosed with Crohn’s disease. Magnetic Resonance Imaging (MRI) is a medical imaging technique used to visualise internal structures of the body in detail by applying magnetic field and radio frequency energy pulses. Magnetic Resonance Enterography (MRE) entails the use of MRI sequences to best show the small bowel and colon after patients drink approx 1.5 l of liquid (oral contrast) to help outline the bowel. Ultrasound is a medical imaging technique that can generate images of the internal body structures by detecting reflections from high frequency sound waves generated by a dedicated transducer (“probe”). Small Bowel Ultrasound (SBUS) uses the same principle as all other ultrasound examinations but with specific attention directed to the small bowel. All patients in this study will have had either MRE or SBUS at diagnosis. The researchers request access to their routine care data.

Interventions

Inclusion criteria

METRIC cohort: 1. Enrolled in the METRIC study, new diagnosis cohort AND 2. Formed part of the final new diagnosis cohort (i.e. with a confirmed diagnosis of Crohn's disease and underwent relevant study interventions and follow-up). METRIC new diagnosis cohort inclusion criteria were: 2.1. Aged 16 years or more 2.2. Newly diagnosed with Crohn's disease based on endoscopic, histological, clinical and radiological findings, OR 2.3. Highly suspected of Crohn's disease based on characteristic endoscopic, imaging and/or histological features but pending final diagnosis (only participants who ultimately were confirmed to have Crohn's disease will continue in this extension study) AND 3. Have given signed consent to be part of METRIC-EF Retrospective cohort: 1. Aged 16 years or more and received a new diagnosis of Crohn's disease based on endoscopic, histological, clinical and radiological findings 2. Dedicated enteric imaging (either MRE or SBUS) acquired according to the standards of the METRIC study and performed either < 3 months after, or < 3 months prior to the new diagnosis of Crohn's disease 3. Institutional practice is to perform MRE or SBUS in all patients with newly diagnosed Crohn's disease 4. Has > 4 years clinical follow-up data, or anticipated to have such follow-up data by the time of consensus endpoint meetings (mid 2020) 5. Have given signed consent to be part of METRIC-EF

Exclusion criteria

METRIC cohort: 1. Enrolled in the METRIC study but not part of the final new diagnosis cohort

Locations

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