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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
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 26, 2022
Last Updated
May 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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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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