Comparative Effectiveness of MR Enterography

University of Michigan

Status: Completed

Conditions: Crohns Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01593462

HUM00046580

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Pediatric Small Bowel Crohn's Disease

Experimental group

Description:

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.

Treatment:

Procedure: The Ultrasound scan, (UEI) Ultrasound Elastography Imaging with ARFI (acoustic radiation force impulse)

Procedure: MRE (magnetic resonance enterography)

Behavioral: Study Questionnaires