Trials / Completed
CompletedNCT03340519
Early MRI Prediction of Crohns
Early MRI Prediction of Response to Medical Therapy and Mucosal Healing in Small Bowel Crohn's Disease
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 35 (actual)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- All
- Age
- 11 Years – 25 Years
- Healthy volunteers
- Accepted
Summary
The investigators plan a prospective study designed to optimize and translate noncontrast, novel Magnetic Resonance Imaging (MRI) techniques for detecting and measuring intestinal inflammation as well as for allowing early prediction of response to medical therapy in small bowel Crohn's Disease (CD).
Detailed description
The investigators plan to evaluate novel MRI techniques to measure: 1) mesenteric/intestinal blood flow using phase-contrast cine MRI, 2) intestinal motility (peristalsis) using dynamic cine MRI, and 3) bowel wall perfusion and molecular water diffusion. Precise objective measurements of diseased bowel blood flow (in ml/min) and bowel motility (in contractions per minute) are not currently used in the clinical care of CD patients, while diffusion-weighted imaging is typically used in a qualitative manner. None of these techniques have been evaluated for predicting eventual response to therapy or correlated with endoscopic mucosal healing in pediatric or adult CD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MR Imaging | Novel MR imaging will be performed to provide bowel anatomic and functional data |
Timeline
- Start date
- 2018-12-17
- Primary completion
- 2021-10-25
- Completion
- 2024-12-18
- First posted
- 2017-11-13
- Last updated
- 2025-02-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03340519. Inclusion in this directory is not an endorsement.