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

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.

We 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease (CD)
• Intervention / Treatment: Procedure: MRI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LISE LACLAUTRE; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI without a distension agent; Patients with Crohn's disease will have an MRI without 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.
Active Comparator: MRI with a distension agent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Clermont score (C-Score)	quantitative variable, whose concordance will be assessed by Lin's coefficient.	From enrollement to the end of the follow up at 7th day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MaRIA score	quantitative variable, whose concordance will be assessed by Lin's coefficient	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	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)	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)	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)	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)	After each MRI

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Anthony BUISSON, Professor, cl

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: MRI; Crohn Disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: PHRC I 2025 HORDONNEAU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No