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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01671579
First received: August 20, 2012
Last updated: June 4, 2014
Last verified: June 2014

August 20, 2012
June 4, 2014
March 2012
August 2015   (final data collection date for primary outcome measure)
Follow-up of known small bowel Crohn disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
A variety of imaging findings will be documented by ultrasound and correlated with the imaging findings from the clinically ordered MRE exam to determine the efficacy of bowel ultrasound in the follow-up of small bowel Crohn disease in pediatric subjects.
Same as current
Complete list of historical versions of study NCT01671579 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease
Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Sm. Bowel Crohn Disease.

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.

25-30% of individuals with Crohn disease present during childhood or adolescence, and the incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging technology for bowel assessment and offers several advantages over MRE, including lower cost, shorter exam time, and lack of need for sedation and contrast materials and bowel medication. The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known pediatric small bowel Crohn disease using MRE and the reference standard.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Crohn Disease
  • 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.
    Other Names:
    • abdominal ultrasound imaging
    • ultrasound elasticity imaging
  • 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.
Pediatric small bowel Crohn disease
Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.
Interventions:
  • Procedure: Bowel ultrasound
  • Procedure: magnetic resonance enterography (MRE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2016
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or younger
  • Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging follow-up with MR enterography.

Exclusion Criteria:

  • Subjects with suspected or newly diagnosed Crohn disease
  • Subject who have the following in their body may not undergo MRE imaging:

    • Metal chips/shrapnel
    • Surgical clips
    • Artificial joints
    • Metallic bone plates
    • Prosthetic devices
    • Heart pacemakers
    • Clips in or around the eye balls
    • artificial heart valves
    • Bullet fragments
    • Chemotherapy or insulin pumps
Both
10 Years to 18 Years
No
Contact: Jonathan R. Dillman, M.D. (734) 763-2520 jonadill@umich.edu
Contact: James Pool (734) 615-7800 jampool@umich.edu
United States
 
NCT01671579
HUM00061688
Yes
Jonathan R. Dillman M.D., University of Michigan
University of Michigan
Not Provided
Principal Investigator: Jonathan R. Dillman University of Michigan
University of Michigan
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP