Perfluorobutane-enhanced Ultrasound as a Diagnostic Tool for Hepatocellular Carcinoma in Individuals With High Risk: Intraindividual Comparison With Sulfur Hexafluoride-enhanced Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
CEUS with perfluorobutane and sulfur hexafluoride
Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion.
干预措施: contrast enhanced ultrasound (Diagnostic Test)
CEUS with perfluorobutane and sulfur hexafluoride
Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion.
干预措施: Dynamic CT (Diagnostic Test)
CEUS with perfluorobutane and sulfur hexafluoride
Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion.
干预措施: Liver MRI (Diagnostic Test)
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
Jeong Min Lee
Professor
Seoul National University Hospital