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

NCT07471438 | Not Yet Recruiting

• 1 other identifier: PHRC I 2025 HORDONNEAU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Crohn Disease (CD)

Keywords

Crohn Disease; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• MaRIA score

  From enrollement to the end of the follow up at 7th day

• Transmural inflammatory activity

  From enrollement to the end of the follow up at 7th day

• Numerical acceptability scale

  From enrollement to the end of the follow up at 7th day

• Numerical scale for intestinal distension

  From enrollement to the end of the follow up at 7th day

• Likert scale for intestinal distension quality

  From enrollement to the end of the follow up at 7th day

Study Arms (2)

MRI without a distension agent

EXPERIMENTAL

Patients with Crohn's disease will have an MRI without a contrast agent

Procedure: MRI

MRI with a distension agent

ACTIVE COMPARATOR

Patients with Crohn's disease will have an MRI with a contrast agent

Procedure: MRI

Interventions

MRI PROCEDURE

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.

MRI with a distension agent; MRI without a distension agent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Anthony BUISSON, Professor

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  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will have two MRI scans one week apart, one with and one without contrast agent.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-01

Locations

FR (1)