跳至主要内容
临床试验/NCT04847726
NCT04847726已完成不适用

Perfluorobutane-enhanced Ultrasound as a Diagnostic Tool for Hepatocellular Carcinoma in Individuals With High Risk: Intraindividual Comparison With Sulfur Hexafluoride-enhanced Ultrasound

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
2
主要终点
Diagnostic accuracy for HCC: non-inferiority test

研究概览

简要总结

Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC.

详细描述

The investigators would compare the diagnostic performance for HCC at high-risk individuals between both USG contrast agents.

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

入选标准

  • high-risk for HCC (liver cirrhosis, chronic hepatitis B)
  • treatment-naive hepatic nodule (>= 1cm) on preceding CT, MR or ultrasound

排除标准

  • severe cardiopulmonary dysfunction
  • pregnancy
  • refusal to enroll study

结局指标

主要结局

Diagnostic accuracy for HCC: non-inferiority test

时间窗: up to 3 months

The per-lesion diagnostic accuracy for HCC of CEUS with perfluorobutane and sulfur hexafluoride using the same diagnostic criteria (arterial phase hyperenehancement with mild and late (≥ 60 sec) washout).

次要结局

  • Diagnostic performance of perfulorobutane enhanced USG using different definition of washout(up to 3 months)

研究者

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

Jeong Min Lee

Professor

Seoul National University Hospital

研究点 (2)

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