Role of Sonazoid-enhanced Ultrasound as a Secondary Diagnostic Modality in Non-invasive Diagnostic Algorithms for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.
研究概览
简要总结
To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma (HCC) among at-risks observations.
详细描述
The purpose of our study was to evaluate the diagnostic ability of CEUS with perflubutane to identify HCC on the indeterminate observation in Gd-EOB-MRI and to establish the role of CEUS as a second-line (post-Gd-EOB-MRI) modality for HCC diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at risk of HCC by Liver Imaging Reporting and Data System (LI-RADS)
- •at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance using US, CT or MRI
- •signed informed consent
排除标准
- •congestive hepatopathies
- •severe cardiovascular dysfunction
- •no recent cross-sectional images within 4 weeks
- •suboptimal cross-sectional images quality
结局指标
主要结局
Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS.
时间窗: 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.
Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS.
Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation
时间窗: 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks.
Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI.
次要结局
- Comparing image characters between two types of ultrasound contrast media(For 3 days after undergoing CEUS to check the complication of CEUS, per each participants.)
研究者
Jeong Min Lee
Pf.
Seoul National University Hospital