The Role of Contrast Enhanced Ultrasond (Ceus), in the Characterization of Focal Liver Lesions Indeterminate to Second-level Methods
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CEUS diagnostic accuracy
研究概览
简要总结
The primary objective of the study is to determine the accuracy of CEUS in characterizing (as benign or malignant) focal liver lesions for which CT, MRI and/or PET have not been conclusive.
详细描述
The study conducted will be a non-profit, observational, non-pharmacological, cross-sectional, but also partly cohort, retrospective and prospective study. The study is cross-sectional in nature, but will require 6 months of follow-up to evaluate the gold standard reference outcome in patients diagnosed with a benign pathology that does not require further investigations, and in patients with suspected malignant lesion for which histological diagnosis has not been performed on biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years.
- •CEUS performed performed in the last 6 months a CT, MRI and/or PET not decisive in characterizing a liver lesion.
- •Obtaining informed consent.
排除标准
- •Technical impossibility to perform the ultrasound evaluation.
- •Documented allergy to the ultrasound contrast medium.
结局指标
主要结局
CEUS diagnostic accuracy
时间窗: 2 years
CEUS diagnostic accuracy in determining the nature of focal liver lesions
次要结局
未报告次要终点