US Elastography for Characterizing Focal Lesions in the Liver and Kidney
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue
研究概览
简要总结
This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.
详细描述
PRIMARY OBJECTIVES:
I. To determine the utility of ultrasound elastography in correlation with kidney or liver biopsy or magnetic resonance imaging (MRI) or computed tomography (CT) results.
OUTLINE:
Patients undergo ultrasound elastography.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •There are no restrictions on life expectancy
- •Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
- •Patients of any ethnic background
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients should not be taking other investigational agents
- •No requirements due to co-morbid disease or intercurrent illness, as needed
- •No restrictions on allergic reactions as no imaging agent will be used
- •Concomitant medications for treatment of the target lesion
- •Pregnant or nursing patients will be excluded from the study
结局指标
主要结局
Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue
时间窗: Up to 36 months
Suspicious liver and kidney lesions will be analyzed separately on a per-lesion basis. Within each population, the strain ratio of cases and controls will be compared using the Wilcoxon rank sum test, and the analysis will be illustrated using the non-parametric receiver operating characteristic (ROC).
次要结局
未报告次要终点
研究者
Juergen Willmann
Professor of Radiology
Stanford University