Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel

Completed

• Conditions: Crohn Disease

• Registration Number: NCT00587210
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to assess the exam quality and accuracy of MR using a new oral contrast agent for the evaluation of Crohn Disease in the small bowel.

Detailed Description

Crohn Disease is an inflammatory condition that involves the small bowel. Patients usually undergo multiple imaging exams in the diagnosis and surveillance of the disease. CT has been shown to have excellent results for detecting active inflammation. In the United States MR has lagged behind CT in utilization for imaging the small bowel. An advantage of MR over CT is the lack of radiation exposure to the patient. A new oral contrast agent is available that provides good distension of the small bowel and allows improved identification of active inflammation. The purpose of this study is to compare the accuracy of MR to CT using this new oral contrast agent and to assess exam quality.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-07
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Known or suspected Crohn Disease
• Undergoing colonoscopy and CT enterography

Exclusion Criteria

• Contraindication to MR

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
exam quality	one time point

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States