The CONTEXT trial: Real world clinical use of GIQuant-a motility MRI based activity biomarker for small bowel Crohn's disease.

Abstract

BACKGROUND: Motility MRI is a validated marker of small bowel Crohn's disease (CD) activity. Objective assessment of small bowel motility with GIQuant (Motilent, London, U.K.) may have a valuable role to play in personalised patient care. The aim of this study was to assess the impact of implementing GIQuant on clinical impressions around treatment response in small bowel CD.

METHODS: Patients with small bowel CD on or starting therapy underwent two MRE scans (~1 year apart) including motility MRI (mMRI) imaging. Twelve gastroenterologists from six U.K. participating centres evaluated patient response based on standard of care tests, grading them on a 6-point scale (much/somewhat/slightly worse through to slightly/somewhat/much better). After initial assessment, GIQuant scores and percentage change were revealed to the gastroenterologist who then updated their response assessment with this information. GIQuant scores at baseline and follow up are reported along with magnitude of change in clinically categorised responders and non-responders.

RESULTS: Over the study period of 3.6 years a total of 253 patients (61% male), with ileal (52%) or ileocolonic (48%) CD underwent 506 MRE scans, with a median 10.4-month gap (range 2 to 36) between scans. In 120/253 (47%) patients, gastroenterologists reported a change in their impression of patient status (one step change or greater) after reviewing the GIQuant results with 55/253 (22%) reversing their overall assessment (between deterioration or improvement) across the two time points. In clinical responders, the GIQuant score increased from 123 to 163 (32% increase), P < .001 with non-responders showing a 2 point decrease in score (P = .9).

CONCLUSION: GIQuant as a measure of motility MRI demonstrated robust utility to track the response of small bowel Crohn's activity to therapeutic intervention across time points.