Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection

NCT06526234 | Completed

• 1 other identifier: 2024PI153
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Entero-MRI is indicated in Crohn's disease as part of the initial work-up or follow-up (to assess response to treatment, complications). The protocol for carrying out the examination complies with precise specifications set out in international recommendations. To perform the test, the small intestine must be distended with a hyperosmolar product. This protocol is applied to all patients, with no distinction or adaptation. The total duration of the examination is sometimes difficult for patients to bear. Ingestion of the product to obtain distension of the small intestine is often poorly tolerated by patients. In a number of cases, the entero-MRI may have been normal due to symptomatology regression or other diagnosis. The patient therefore underwent a complete examination similar to that of a patient with a pathology requiring characterization. In this context, the investigators hypothesize that fast MR sequences are sufficient to discriminate between normal and abnormal examinations.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Presence or absence of lesions detected visually by a radiologist on injection-free sequences versus conventional MR enterography.

  Baseline (day 0)

Study Arms (1)

Patients with Crohn's disease or suspected Crohn's disease

Device: MRI

Interventions

MRI DEVICE

MR enterography

Patients with Crohn's disease or suspected Crohn's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with MR enterography examination for follow-up or suspected Crohn's disease

You may qualify if:

• Patient with MR enterography examination for follow-up or suspected Crohn's disease

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, CHRU de Nancy, 54511, France

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: January 1, 2023
• Primary Completion: May 31, 2023
• Study Completion: November 30, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

FR (1)