NCT00162058已完成2 期
An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study.
研究概览
简要总结
To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Diagnosed with 1 but <7 focal liver lesions
- •Scheduled for liver biopsy within 30 days of study
- •Scheduled for CT or MR within 30 days of study
排除标准
- •Critically ill subjects
- •Subjects with right-to-left shunts
结局指标
主要结局
The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study.
次要结局
- The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.
研究者
研究点 (1)
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