DWI MR-enterography Without or With Bowel Cleansing to Assess Intestinal Inflammatory Activity in the Follow-up of Crohn's Disease (ENTEDIF)
Primary Purpose
Crohn Disease, Bowel Cleansing, Apparent Diffusion Coefficient
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MR-enterography
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn Disease focused on measuring Crohn Disease, diffusion-weighted imaging, MR-enterography, bowel cleansing, apparent diffusion coefficient
Eligibility Criteria
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
Sites / Locations
- CHU AmiensRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MR-enterography
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05354609
First Posted
April 26, 2022
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05354609
Brief Title
DWI MR-enterography Without or With Bowel Cleansing to Assess Intestinal Inflammatory Activity in the Follow-up of Crohn's Disease
Acronym
ENTEDIF
Official Title
Assessment of Intestinal Inflammatory Activity in the Follow-up of Patients With Crohn's Disease: Diffusion-weighted MR-enterography, Without or With Bowel Cleansing, Compared With Standard MR-enterography
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Bowel Cleansing, Apparent Diffusion Coefficient
Keywords
Crohn Disease, diffusion-weighted imaging, MR-enterography, bowel cleansing, apparent diffusion coefficient
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MR-enterography
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
MR-enterography
Intervention Description
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.
Primary Outcome Measure Information:
Title
variation of inflammatory activity localisation number in the main bowel
Description
variation of inflammatory activity localisation number in the main bowel between diffusion entero-MRI with bowel cleansing versus standard enteroMRI
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raphaël Pichois, MD
Phone
03 22 08 80 51
Email
pichois.raphael@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphaël PIchois, MD
Email
pichois.raphael@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Mathurin Fumery, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DWI MR-enterography Without or With Bowel Cleansing to Assess Intestinal Inflammatory Activity in the Follow-up of Crohn's Disease
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