MRI of the small bowel and colon in determining disease activity in patients with Crohn*s disease
Recruiting
- Conditions
- Inflammatory Bowel Disease10017969Crohn's disease
- Registration Number
- NL-OMON36153
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
Proven Crohn*s disease (by endoscopy or histopathology)
Scheduled to undergo an ileocolonoscopy as part of their clinical follow-up
Scheduled for MRI as part of their clinical follow-up
Exclusion Criteria
Under 18 years of age
General contraindications to MRI (claustrophobia, pregnancy, sever renal insufficiency) and MRI intravenous contrast agent.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter will be the sensitivity and specificity of MRI of the<br /><br>colon and small bowel in grading disease activity in CD patients. Also, the<br /><br>added value of MRI of the colon willl be compared to routine MRI of the small<br /><br>bowel. Colonoscopy will serve as the reference standard.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints will be the comparison of the MRI findings (additional<br /><br>MR imaging with DWI, T1-map and dynamic imaging (DCE-MRI)), compared to the<br /><br>Harvey Bradshaw index and C-reactive protein (CRP) for grading disease activity<br /><br>in CD patients.<br /><br><br /><br>The study will acquire these data in order to develop and assess ICT tools for<br /><br>objective measurement of features of Crohn*s disease such as the bowel wall<br /><br>thickness. For the developing of the ICT tools we will share our data with<br /><br>European collaborators in the framework of an EU FP7 consortium (VIGOR++). </p><br>