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

NCT07471438 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-13

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Anthony BUISSON, Professor · cl

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07471438 on ClinicalTrials.gov