Does distending the intestine change how we see Crohn's activity on MRI?
Official title: Study of Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease.
Run by University Hospital, Clermont-Ferrand · NCT07471438 · Data updated 2026-11-12
This study tests whether adding an intestinal distensionagent before MRI changes the measurement of Crohn's inflammation in adults with ileal or colonic disease.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 2 sites (Amiens and 1 other locations) |
| Status | Recruiting |
| Started | April 22, 2026 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07471438 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with Crohn's disease involving the ileum and/or colon who require MR enterography for activity reassessment and can undergo two MRIs in one week.
✕Probably not a fit
Patients with isolated colonic Crohn's disease, those unable to undergo MRI, or those unlikely to benefit from imaging changes may see no direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, cross-sectional study enrolling adults with Crohn's disease who need MRI-based activity reassessment. Each participant will have two MR enterography scans in the same week: one without distension and one with distension, using identical MRI protocols and gadolinium contrast. Images will be anonymized and reviewed centrally by two blinded radiologists to determine concordance using a standardized C-score and Lin's coefficient. The aim is to see if using distension affects the agreement between MRI assessments of inflammatory activity. The study does not seek a therapeutic intervention but evaluates imaging methodology to potentially improve consistency in disease monitoring.
Why it matters
Potential benefit: If distension improves concordance, MRI-based assessments could become more reliable for guiding treatment decisions in Crohn's disease.
How similar studies have gone: Previous imaging studies suggest that protocol variations can affect MRI interpretation, but this exact distension approach with blinded central review is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with Crohn's disease according to European recommendations (ECCO) ≥ 18 years of age * With known or suspected ileal ± colonic involvement * Requiring reassessment of disease inflammatory activity according to the clinician * Able to give informed consent to participate in the research. * Affiliation with a Social Security scheme * Agreeing to undergo two MRIs in the same week Exclusion Criteria: * Isolated colonic Crohn's disease * Resection \> 1 m of small intestine * Severe obstructive symptoms defined according to CDOS (Crohn's disease obstructive symptoms score) * Uncontrolled intra-abdominal abscess * Isolated anoperineal lesions * Prevention of postoperative endoscopic recurrence * Temporary or permanent stoma * Total colectomy * Contraindication to MRI * Pregnant or breastfeeding women * Protected adults (under guardianship, trusteeship, family authorization, future protection mandate, with representation relating to the person)
Where it's running
-
CHU d'Amiens
Amiens, France Recruiting -
CHU de Clermont-Ferrand
Clermont-Ferrand, France Not yet recruiting
Study contacts
- Principal investigator: Anthony BUISSON, Professor — cl
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Reduce ultra-processed foods to help kids with Crohn's stay in remission longer
This study tests whether and how reducing ultra-processed foods with dietitian guidance helps children and teens with Crohn's disease stay in remission longer.
-
Endoscopic stricturotomy vs balloon dilation for small bowel Crohn’s stricture
This trial tests whether endoscopic stricturotomy can be safely and effectively used to treat small bowel fibrotic strictures in Crohn’s disease, compared with endoscopic balloon dilation.
-
Prediction of postoperative recurrence in Crohn's disease after surgery
A multicenter study will test a multimodal model to predict which Crohn's patients are likely to have disease recur after intestinal resection.
-
Perianal fistula imaging comparison using TPUS, MRI, EUS, and EUA
This study tests how well four imaging methods—transperineal ultrasound, MRI, endoscopic ultrasound, and examination under anesthesia—detect and describe perianal fistulas in adults with Crohn's disease or unknown cause.
-
Familial IBD Early Risk
This study tests whether clinical, environmental, and immune factors in first-degree relatives of people with Crohn’s disease or ulcerative colitis can predict who will develop IBD.
-
Impact of sucralose on gut health in Crohn's disease
This study tests whether the non-nutritive sweetener sucralose changes gut bacteria in adults with Crohn's disease compared to healthy controls.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.