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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.
Verified March 2013 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: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Crohn Disease
 Procedure: Bowel ultrasound
Procedure: magnetic resonance enterography (MRE)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Sm. Bowel Crohn Disease.

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671579

Contacts
Contact: Jonathan R. Dillman, M.D. (734) 763-2520 jonadill@umich.edu
Contact: James Pool (734) 615-7800 jampool@umich.edu

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jonathan R. Dillman, M.D.     734-763-2520     jonadill@umich.edu    
Contact: James Pool     734-615-7800     jampool@umich.edu    
Principal Investigator: Jonathan R. Dillman, M.D.            
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jonathan R. Dillman University of Michigan
  More Information

No publications provided

Responsible Party: Jonathan R. Dillman M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01671579     History of Changes
Other Study ID Numbers: HUM00061688
Study First Received: August 20, 2012
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013