Study Comparing Inflammatory Activity Using Enteric MRI With and Without Intestinal Distension Products in Adults With Ileal Crohns Disease

What this Trial Is About

Crohns disease is a chronic inflammatory bowel condition that can greatly reduce quality of life and often leads to intestinal damage requiring surgery. The study focuses on improving how disease activity in the ileum is assessed by comparing MRI scans done with and without an intestinal distension product. Researchers aim to see if MRI without distension can reliably measure inflammation as well as the standard MRI with distension, potentially improving patient comfort and acceptance. Participants with ileal or colonic Crohns disease will undergo two MRI scans within a week one without any intestinal distension agent and one with the standard distension product. Both will use gadolinium contrast and identical MRI protocols. Images will be reviewed centrally by expert radiologists who are blinded to clinical data to evaluate inflammatory activity scores and their agreement between the two MRI methods. During the study, participants will have two MR enterography scans spaced 2 to 7 days apart. Researchers will measure inflammatory activity using the Modified Clermont score and other imaging scores, assess intestinal distension quality and acceptability, and monitor side effects occurring within 48 hours after each scan. The study aims to improve MRI assessment methods while ensuring patient safety and comfort over the short follow-up period.

Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.