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

NCT ID: NCT00587210

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2008-12-31

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.

Conditions

Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Suspected or known Crohn Disease

Suspected or known Crohn Disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Contraindication to MR

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jeff Fidler

Professor of Radiology College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeff L Fidler, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

381-04

Identifier Type: -

Identifier Source: org_study_id