Comparative Effectiveness of MR Enterography

Not Applicable

Completed

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

• Registration Number: NCT01593462
• Lead Sponsor: University of Michigan

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric Small Bowel Crohn's Disease	Study Questionnaires	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 may not be performed as part of your routine care.
Pediatric Small Bowel Crohn's Disease	The Ultrasound scan, (UEI) Ultrasound Elastography Imaging with ARFI (acoustic radiation force impulse)	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 may not be performed as part of your routine care.
Pediatric Small Bowel Crohn's Disease	MRE (magnetic resonance enterography)	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 may not be performed as part of your routine care.

Primary Outcome Measures

Name	Time	Method
Effectiveness of MR Enterography, Enteric US, US Elastography Imaging with ARFI	6 months	To assess accuracy in imaging techniques

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness and patient imaging preferences	6 months	To compare imaging costs and imaging preferences of the patient.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States