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Active, not recruiting Not applicable

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

NCT05354609 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-04-26
Last updated
2025-11-19

Condition(s) studied

Crohn DiseaseBowel CleansingApparent Diffusion Coefficient

Investigational drug(s) / intervention(s)

MR-enterography

MR-enterography: 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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05354609 on ClinicalTrials.gov ↗ ← All trials in France