NCT03742453Unknown不适用
Evaluation of Diagnostic Accuracy of Contrast-enhanced Ultrasound (CEUS) and Gadoxetic Acid-enhanced Liver MRI for Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Diagnostic performance of CEUS for diagnosing HCC
研究概览
简要总结
This study aims to compare the diagnostic accuracy of Contrast-enhanced ultrasound (CEUS) for diagnosing hepatocellular carcinoma (HCC) with that of gadoxetic acid-enhanced liver magnetic resonance imaging (MRI) using non-invasive diagnostic criteria (American Association for the Study of Liver Disease (AASLD or Liver Imaging Reporting and Data System (LI-RADS) v2018 and Korean Liver Cancer Study Group- National Cancer Center Korea (KLCSG-NCC) v2018).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk group of developing HCC
- •hepatic nodule equal to or larger than 1cm on ultrasound or computed tomography (CT)
- •newly detected nodule (equal to or larger than 1cm, at least 2cm distance from radiofrequency ablation (RFA) site or resection margin) in patients with history of hepatic resection or RFA for HCC AND in remission more than a year
- •scheduled for gadoxetic acid-enhanced liver MRI
- •signed informed consent
排除标准
- •hypersensitivity for ultrasound contrast media
- •pregnancy
- •history of recent treatment for HCC in a year
- •standard of reference is not available
- •severe cardiopulmonary disease (right to left shunt, severe pulmonary hypertension, uncontrolled hypertension, etc)
结局指标
主要结局
Diagnostic performance of CEUS for diagnosing HCC
时间窗: 3 months after CEUS
accuracy, sensitivity, specificity of CEUS for HCC diagnosis
次要结局
- Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using KLCSG-NCC guidelinev2018(3 months after MRI)
- Diagnostic performance of gadoxetic-acid liver MRI for diagnosing HCC using LI-RADSv2018(3 months after MRI)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital
研究点 (1)
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