Comparative Effectiveness of MR Enterography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohns Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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 may not be performed as part of your routine care.

Group Type EXPERIMENTAL

MRE (magnetic resonance enterography)

Intervention Type PROCEDURE

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.

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

Intervention Type PROCEDURE

The US UEI will take about 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.

Study Questionnaires

Intervention Type BEHAVIORAL

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. The study questionnaires should take no longer than 10 to 40 minutes to complete.

Interventions

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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.

Intervention Type PROCEDURE

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

The US UEI will take about 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.

Intervention Type PROCEDURE

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. The study questionnaires should take no longer than 10 to 40 minutes to complete.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No