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Completed

NCT Number: NCT01593462

Comparative Effectiveness of MR Enterography

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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Key information

Conditions

Crohns Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRE (magnetic resonance enterography)

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)

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

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.

Primary outcomes

  1. Effectiveness of MR Enterography, Enteric US, US Elastography Imaging with ARFI

    Time frame: 6 months

    To assess accuracy in imaging techniques

Secondary outcomes

  1. Cost effectiveness and patient imaging preferences

    Time frame: 6 months

    To compare imaging costs and imaging preferences of the patient.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Comparative Effectiveness of MR Enterography, Enteric Ultrasound, and Ultrasound Elastography Imaging in the Evaluation of Pediatric Small Bowel Crohn Disease

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 8, 2012
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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