跳至主要内容
临床试验/NCT01593462
NCT01593462已完成不适用

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

University of Michigan2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Effectiveness of MR Enterography, Enteric US, US Elastography Imaging with ARFI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

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

时间窗: 6 months

To assess accuracy in imaging techniques

次要结局

  • Cost effectiveness and patient imaging preferences(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan R. Dillman M.D.

Principal Investigator

University of Michigan

研究点 (2)

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