Principal Component Regression Based Contrast Enhanced Ultrasound Evaluating System in the Management of BI-RADS 4A Breast Nodules
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- surgery or biopsy
研究概览
简要总结
The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS).
详细描述
The aim of this study was to investigate the added value of Principal Component Regression (PCR) based contrast-enhanced ultrasound (CEUS) for differentiating low risk patients with breast nodules categorized as 4A using the Breast Imaging Reporting and Data System (BI-RADS). The study included patients with 4A nodules confirmed by core biopsy and/or surgery. The CEUS parameters were assessed and PCR scores were calculated to evaluated the added value in BI-RADS 4A nodules.
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
- •patients with BI-RADS 4A breast lesion
排除标准
- •(i) absence of a pathologic diagnosis; (ii) presence of breast nodules that were too large to compare with normal parenchyma; (iii) patients with radiotherapy and chemotherapy of breast cancer; and (iv) skin disorders.
结局指标
主要结局
surgery or biopsy
时间窗: up to 3 months
According to the PCR result, if it's positive, the nodule category was maintained, however, if it's negative, the nodule was downgraded. all nodules were submitted to biopsy or biopsy.
次要结局
未报告次要终点