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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587210
First received: December 21, 2007
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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.


Condition
Crohn Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a New Oral Contrast Agent for MR Enterography in the Assessment of Crohn Disease in the Small Bowel

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • exam quality [ Time Frame: one time point ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of MR [ Time Frame: one time point ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: June 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Suspected or known Crohn Disease

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Gastroenteroloy Clinic; Inflammatory Bowel Disease Clinic

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindication to MR
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587210

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jeff L Fidler, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Jeff L. Fidler, MD- principal investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587210     History of Changes
Other Study ID Numbers: 381-04
Study First Received: December 21, 2007
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Crohn Disease
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014