跳至主要内容
临床试验/NCT03731923
NCT03731923进行中(未招募)不适用

MR Value: Clinical Feasibility of Abbreviated MR Protocol for HCC Surveillance in High-risk Group

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2018年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
257
试验地点
2
主要终点
Sensitivity for detecting HCC

研究概览

简要总结

This study aims to investigate the clinical feasibility of abbreviated liver MRI for HCC surveillance in a high-risk group.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • high risk of HCC development (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)
  • no history of HCC
  • on surveillance of HCC using ultrasonography
  • sign informed consent

排除标准

  • history of HCC
  • congestive hepatopathy
  • iron deposition
  • any absolute or relative contra-indication of contrast-enhanced MRI

结局指标

主要结局

Sensitivity for detecting HCC

时间窗: 12 months after last MRI

Sensitivity for detecting HCC

次要结局

  • Specificity for detecting HCC(12 months after last MRI)
  • Image quality of abbreviated liver MRI(12 months after last MRI)
  • Table time of abbreviated MRI(1 day after each MRI)
  • In-room time of abbreviated MRI(1 day after each MRI)
  • Sensitivity for detecting early stage HCC(12 months after last MRI)
  • Specificity for detecting early stage HCC(12 months after last MRI)

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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