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Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease

NCT01671579 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-01-25

No results posted yet for this study

Summary

To establish the accuracy of bowel ultrasound in the follow-up of known (previously diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance imaging technology used to obtain detailed images of the small bowel) as the reference standard.

Conditions

  • Crohn Disease

Interventions

PROCEDURE

Bowel ultrasound

The ultrasound imaging will take place prior to the clinically ordered MRE exam. The subject will be asked to lie on the ultrasound table for approximately 60 minutes while a variety of ultrasound images are completed.

PROCEDURE

magnetic resonance enterography (MRE)

The subject will have a small intravenous (IV) catheter placed in on of their arms before the MRE exam. Medications called Glucagon and MultiHance will be given thru the IV catheter during the imaging study. The glucagon will decrease the movement of the intestines, which helps provide better images of the bowel. MultiHance is a contrast that helps create clearer MRE images. In addition to the MultiHance, the subject will be given an oral contrast medication called VoLumen to drink approximately 45 minutes before the MRE imaging is started. These medications are used for all clinically necessary MRE studies performed in children and adults at the UMHS. The MRE will take approximately 50 to 60 minutes to complete.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Jonathan R. Dillman · University of Michigan

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-07-31
Completion
2017-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01671579 on ClinicalTrials.gov