跳至主要内容
临床试验/NCT01781208
NCT01781208已完成不适用

Ultrasound Based Acoustic Radiation Force Impulse, Shear Wave Velocity Imaging in Pediatric Patients Undergoing Liver Biopsy

University of Michigan2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2012年11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
62
试验地点
2
主要终点
ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score

研究概览

简要总结

ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.

详细描述

A new technique based on ultrasound, known as Acoustic Radiation Force Impulse (ARFI) imaging is performed using standard approved ultrasound machines and transducers. The sound waves or impulses are generated in a different pattern and offer information on the stiffness of the tissue. This new technique will be evaluated for usefulness in diagnosing different liver conditions.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or younger
  • Scheduled to have a needle biopsy of the liver at
  • C.S. Mott Children's Hospital or
  • Dept. of Radiology at the Univ. of Michigan Hospital
  • Scheduled to have an abdominal ultrasound to evaluate your liver (with no known liver disease)

排除标准

  • None to list

结局指标

主要结局

ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score

时间窗: 10 minutes

Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures. Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis.

次要结局

未报告次要终点

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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