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临床试验/NCT03637959
NCT03637959已完成不适用

Liver Fibrosis Evaluation Using Ultrasound Shear Wave Imaging

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2017年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
270
试验地点
2
主要终点
Liver Stiffness Measured by MRE

研究概览

简要总结

The Researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.

详细描述

Utilizing vibrating transducer, receiver and speaker in differing sequences, while collecting ultrasound liver tissue elastography measurements during participant breath holds. Participants fast for a minimum of four hours and are positioned lying on left side with knees slightly bent.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers or patients who are scheduled for clinically indicated liver MRE for fibrosis staging.
  • Age 18 to 80.

排除标准

  • Subjects lacking capacity to consent
  • Subjects with unreliable ultrasound or MRE measurements.
  • Pregnant women.

结局指标

主要结局

Liver Stiffness Measured by MRE

时间窗: Baseline, approximately 1 day

Liver stiffness measured by standard of care Magnetic Resonance Elastography reported in Kilopascals (kPa) (used as a benchmark reference in this study).

Liver Stiffness Measured by Mechanical Vibrations With Ultrasound Shear Wave Imaging

时间窗: Baseline, approximately 1 day

Liver stiffness measured by Mechanical Vibrations with Ultrasound Shear Wave Imaging reported in kilopascal (kPa).

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shiago Chen

Principal Investigator

Mayo Clinic

研究点 (2)

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