- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06526234
Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection (Fast-MR)
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
CHRU de Nancy
-
Vandœuvre-lès-Nancy, CHRU de Nancy, France, 54511
- CHRU Nancy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patient with MR enterography examination for follow-up or suspected Crohn's disease
No Exclusion Criteria.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Crohn's disease or suspected Crohn's disease
|
MR enterography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Presence or absence of lesions detected visually by a radiologist on injection-free sequences versus conventional MR enterography.
Time Frame: Baseline (day 0)
|
Baseline (day 0)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024PI153
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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