DWI MR-enterography Without or With Bowel Cleansing to Assess Intestinal Inflammatory Activity in the Follow-up of Crohn's Disease

NCT05354609 | Active Not Recruiting

• 1 other identifier: PI2022_843_0013
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Since 2009, many studies tend to prove the effectiveness of diffusion-weighted MR-enterography in the assessment of inflammatory activity in IBD compared to standard MR-enterography, with the emergence of new radiological scores such as the Clermont score. Diffusion-weighted MRI (DWI) is a faster technique and does not require the injection of gadoline contrast medium, which is a desirable in view of recent data on their long-term adverse effects (intracerebral deposits, nephrogenic systemic fibrosis). The advent of 3T MRI, which provides a better signal, a better spatial resolution or the same examination quality in a shorter time, seems promising for the future of DWI. However, to date, there are still few studies carried out at 3T in this field or even few studies on the possibility of doing away with bowel cleansing, although this is one of the main demands of patients. All patients will undergo a simplified MR-enterography, which includes four sequences, without bowel cleansing or injection. On the same day, the standard MR-enterography will be performed as in clinical practice, after ingestion of the usual oral preparation. Three reading sessions of the examination will be organized at intervals of at least one month by two radiologists specialized in digestive imaging, blinded to the clinical and

Conditions

Crohn Disease; Bowel Cleansing; Apparent Diffusion Coefficient

Keywords

Crohn Disease; diffusion-weighted imaging; MR-enterography; bowel cleansing; apparent diffusion coefficient

Outcome Measures

Primary Outcomes (1)

• variation of inflammatory activity localisation number in the main bowel

  variation of inflammatory activity localisation number in the main bowel between diffusion entero-MRI with bowel cleansing versus standard enteroMRI

  one day

Study Arms (1)

MR-enterography

EXPERIMENTAL

Other: MR-enterography

Interventions

MR-enterography OTHER

All patients will undergo a simplified MR-enterography, which includes four sequences, without bowel cleansing or injection. On the same day, the standard MR-enterography will be performed as in clinical practice, after ingestion of the usual oral preparation.

MR-enterography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient diagnosed with Crohn's disease with bowel involvement for whom a MR-enterography was ordered as part of their follow-up
• Age ≥ 18
• Subject's ability to understand and express opposition
• Affiliation to French social security system

You may not qualify if:

• Any contraindication to MRI
• Allergy to gadolinium chelates
• Claustrophobia
• Major obesity that does not allow the patient to enter the machine's tunnel (whose diameter is 70 cm)
• Pregnant woman
• Person under curators or guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, 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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: April 26, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)