Comparing SonoVue With Sonazoid in the Performance of Contrast Enhanced Ultrasound The Liver Imaging Reporting and Data System (CEUS-LIRADS) in Diagosing HCC: a Prospective Blind Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients.
研究概览
简要总结
The new version of CEUS LI-RADS published at 2018(version 2017). In this study, the investigators aim to investigate the diagnosing performance of CEUS LI-RADS by administrating different contrast agents (SonoVue/ Sonazoid).
详细描述
Independent radiologists from department of ultrasound will report their diagnosing results according to CEUS LI-RADS version 2017 without getting any information about patients. The researcher of this subject will collect all results and evaluated the sensitivity and specificity of CEUS LI-RADS and the diagnosing performance with different contrast agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The sequence of sonovue or sonazoid is blind to participant. The data is blind to the radiologist who is plan to evalutaed the data using CEUS LIRADS version 2017 and the outcome assessor who calculated all data and do the statistical calculation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at risk for HCC with focal liver lesion on conventional ultrasound.
- •history of cirrhosis.
- •historty of HBV infection.
排除标准
- •systemic therapy with sorafenib
- •pretreat lesion
- •patients don't sign the informed consent.
研究组 & 干预措施
Sonovue and Sonazoid Group
Subjects were randomized to receive SonoVue firstly and Sonazid secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at observing room for at least 30min.
Contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio.
干预措施: Sonovue and Sonazoid (Drug)
Sonazoid and Sonovue Group
Subjects were randomized to receive Sonazoid firstly and SonoVue secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at observing room for at least 30min.
contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio.
干预措施: Sonazoid and Sonovue (Drug)
结局指标
主要结局
CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients.
时间窗: 6 months
CEUS LI-RADS® v2017 which is published by ACR is a standardized system for technique, interpretation, reporting, and data collection for contrast-enhanced ultrasound exams in patients at risk for developing HCC.
次要结局
- The sensitivity and specificity of CEUS-LI-RADS by different contrast agencies.(6 months)