An interventional study of MRI in Crohn Disease (CD), sponsored by University Hospital, Clermont-Ferrand. Recruiting at 2 sites in France. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Health services research
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) that can significantly impair patients' quality of life. Due to its transmural nature (affecting the entire thickness of the intestinal wall), it naturally progresses to intestinal destruction (stenosis, fistula), requiring intestinal resection in approximately half of patients during follow-up. The long-term goal for patients is to maintain a normal life, i.e., without symptoms and without intestinal destruction. To this end, short- and medium-term therapeutic goals have evolved in recent years. Clinical remission is not a sufficient goal, as it has not changed the natural history of the disease. The current goal is to achieve a combination of clinical remission and endoscopic mucosal healing, as this is associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection).
Transmural healing assessed by MRI is also a promising goal associated with a reduced risk of adverse outcomes (recurrence of symptoms, hospitalization, intestinal resection). Furthermore, it is associated with a lower risk of progression to intestinal destruction, unlike endoscopic remission. In this context, transmural healing could soon become the benchmark in terms of therapeutic objectives for Crohn's disease, particularly in the ileum. Although enteric MRI is better accepted than colonoscopy by patients with Crohn's disease, in the ACCEPT1 study, nearly half of patients (48.6%) reported the need to use an intestinal distension product (PEG, mannitol, etc.) as a significant obstacle to repeating entero-MRI, while more than a third complained of vomiting (33.7%) or severe diarrhea (35.0%) induced by these same products. Being able to do without the use of distension products would significantly improve the acceptability of entero-MRI.
The investigators hypothesize that an enteric MRI without distension would lead to poorer ileal distension but would allow inflammatory activity scores to be assessed on MRI in a manner similar to an examination with distension, and thus would not impact the need for therapeutic intensification.
This is a prospective, multicenter (5 centers), cross-sectional concordance study including adult patients with ileal and/or colonic Crohn's disease requiring MR enterography for reassessment of disease activity. Patients will undergo two MR enterography scans at 2 and 7 days intervals. The first scan will be performed without a distension agent, and the second with intestinal distension (as is standard practice). A gadolinium-based contrast agent will be used in both MR enterography scans. Furthermore, the MRI protocols and sequences will be identical. The images will be anonymized and uploaded to a dedicated platform for centralized review by two expert radiologists (randomly selected) blinded to clinical data. The primary endpoint will be the C-score (a quantitative variable), the concordance of which will be assessed using Lin's coefficient.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with Crohn's disease will have an MRI without a contrast agent
Procedure: MRI
Patients with Crohn's disease will have an MRI with a contrast agent
Procedure: MRI
All patients included in the study will undergo an MRI without contrast medium in order to compare the inflammatory damage visible on an MRI with contrast agent.
Modified Clermont score (C-Score)
quantitative variable, whose concordance will be assessed by Lin's coefficient.
Time frame: From enrollement to the end of the follow up at 7th day
MaRIA score
quantitative variable, whose concordance will be assessed by Lin's coefficient
Time frame: From enrollement to the end of the follow up at 7th day
Transmural inflammatory activity
defined by a C-score \> 0.5, binary variable, whose concordance will be assessed by the kappa coefficient
Time frame: From enrollement to the end of the follow up at 7th day
Numerical acceptability scale
Numerical acceptability scale from 0 to 10 (10 = perfect acceptability)
Time frame: From enrollement to the end of the follow up at 7th day
Numerical scale for intestinal distension
Numerical scale from 0 to 10 (10 = perfect acceptability)
Time frame: From enrollement to the end of the follow up at 7th day
Likert scale for intestinal distension quality
(0 = very poor, 1 = poor, 2 = fair distension, 3 = good distension, and 4 = excellent distension)
Time frame: From enrollement to the end of the follow up at 7th day
Percentage of side effects of interest within 48 hours of the examination
(diarrhea, fecal urgency, change in stool consistency, vomiting, nausea)
Time frame: After each MRI
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University Hospital, Clermont-Ferrand