Comparative Effectiveness of MR Enterography

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:
NCT01593462
First received: April 26, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine the efficacy of ultrasound imaging compared to MRE (Magnetic Resonance Enterography) a form of magnetic resonance imaging (MRI) in accurately diagnosing and following Small Bowel Crohn Disease (SBCD) in children.


Condition Intervention
Crohns Disease
Procedure: MRE (magnetic resonance enterography)
Procedure: The Ultrasound scan, (UEI) Ultrasound Elastography Imaging with ARFI (acoustic radiation force impulse)
Behavioral: Study Questionnaires

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparative Effectiveness of MR Enterography, Enteric Ultrasound, and Ultrasound Elastography Imaging in the Evaluation of Pediatric Small Bowel Crohn Disease

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Effectiveness of MR Enterography, Enteric US, US Elastography Imaging with ARFI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess accuracy in imaging techniques


Secondary Outcome Measures:
  • Cost effectiveness and patient imaging preferences [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To compare imaging costs and imaging preferences of the patient.


Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pediatric Small Bowel Crohn's Disease
MRE (magnetic resonance enterography) performed 4 weeks after SBCD treatment begins, or ends or treatment changes, or at 6 months whichever comes first. One research MRE will be performed and one MRE may or not be performed as part of your routine care.
Procedure: MRE (magnetic resonance enterography)
The MRE will take approximately 60 minutes to complete. Enrolled subject will have MRE imaging performed at about 4 weeks after treatment for small bowel crohn's disease begins, and when the treatment ends or changes or at 6 months, whichever comes first. The 4 week MRE will be for research purposes only, the treatment end,change or 6 month MRE may or may not be ordered by the treating physician as part of your routine care. If one is not ordered by the treating physician, the subject will have one performed because of the research study.
Procedure: The Ultrasound scan, (UEI) Ultrasound Elastography Imaging with ARFI (acoustic radiation force impulse)
The US UEI will take approximately 60 minutes to perform. This exam will be performed by 2 different radiologists and you will have this completed 5 times over the course of the study. This imaging will be performed with the subject drinking oral contrast material. The US, UEI will be completed at baseline, 2 weeks, 4 weeks, 3 months and at treatment end/change or 6 months, whichever comes first.
Behavioral: Study Questionnaires

The subject and their parent will be asked to answer questionnaires 2 weeks after the first MRE and US exams and again after the last imaging examinations are performed at treatment end/change or 6 months, whichever comes first.

A Pediatric Crohn Disease Activity Index Assessment will be performed at baseline, 2 weeks, 4 weeks, 3 months, and at treatment end/change or 6 months, whichever comes first. Answering the questionnaires should take no longer than 10 to 40 minutes to complete.


Detailed Description:

Computed Tomography (CT) is an imaging tool that exposes patients to radiation, and until recently it was the most commonly used imaging method to evaluate small bowel Crohn disease. Recently, Magnetic Resonance Enterography (MRE) which is a form of magnetic resonance imaging that provides detailed images of the bowel and less frequently, Ultrasound (US) are replacing CT as the standard of care imaging tool at some institutions.

The investigators would like to determine how effective US imaging is compared to MRI imaging in accurately diagnosing and following SBCD in children. Along with enteric ultrasound (EnUS) we will also be comparing a new ultrasound technology called Ultrasound Elastography Imaging (UEI) for this study in which we will be using a second form of UEI called Acoustic Radiation Force Impulse (ARFI). This technique uses sound waves to asses the stiffness properties of soft tissue. The study will compare costs, patient preferences, and imaging accuracy.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients under 18 years age.
  • Recently diagnosed with small bowel crohn's disease and have not received any prior treatment for this condition

Exclusion Criteria:

  • Are pregnant.
  • Require sedation to have the MRE exam.
  • Cannot tolerate small enclosed spaces for 60 minutes.
  • Have kidneys that are poorly functioning (eGFR <30ml/min)
  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 ClinicalTrials.gov identifier: NCT01593462

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

No publications provided

Responsible Party: Jonathan R. Dillman M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01593462     History of Changes
Other Study ID Numbers: HUM00046580
Study First Received: April 26, 2012
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 30, 2014