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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:
ClinicalTrials.gov Identifier:
NCT00587210
First Posted: January 7, 2008
Last Update Posted: January 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeff Fidler, Mayo Clinic
  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 Jeff Fidler, Mayo Clinic:

Primary Outcome Measures:
  • exam quality [ Time Frame: one time point ]

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
Suspected or known Crohn Disease
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Jeff Fidler, Professor of Radiology College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587210     History of Changes
Other Study ID Numbers: 381-04
First Submitted: December 21, 2007
First Posted: January 7, 2008
Last Update Posted: January 22, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeff Fidler, Mayo Clinic:
Crohn Disease
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases