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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2008 by Mayo Clinic. Recruitment status was Active, not recruiting

First Received on December 21, 2007. Last Updated on October 27, 2008 History of Changes

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587210

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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

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 ]

Estimated Enrollment:	40
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2008
Estimated 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

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:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

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:	October 27, 2008
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

ClinicalTrials.gov processed this record on February 09, 2012