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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 January 2016 by Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Jonathan Dillman, MD, Children's Hospital Medical Center, Cincinnati Identifier:
First received: August 20, 2012
Last updated: January 26, 2016
Last verified: January 2016
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: 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:

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Follow-up of known small bowel Crohn disease [ Time Frame: 1 year ]
    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 2017
Estimated Primary Completion Date: August 2016 (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.

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01671579

Contact: Jonathan R. Dillman, M.D. (734) 763-2520
Contact: James Pool (734) 615-7800

United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jonathan R. Dillman, M.D.    734-763-2520   
Contact: James Pool    734-615-7800   
Principal Investigator: Jonathan R. Dillman, M.D.         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Principal Investigator: Jonathan R. Dillman University of Michigan
  More Information

Responsible Party: Jonathan Dillman, MD, Principal Investigator, Children's Hospital Medical Center, Cincinnati Identifier: NCT01671579     History of Changes
Other Study ID Numbers: HUM00061688
Study First Received: August 20, 2012
Last Updated: January 26, 2016

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on May 22, 2017