NCT02226081已完成不适用
Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,273
- 试验地点
- 22
- 主要终点
- Increase in specificity of breast ultrasound imaging when considering stiffness measurements
研究概览
简要总结
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.
详细描述
Chinese women are known to have denser breasts than women in Western countries. Mammography cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should improve the diagnosis of a lesion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •known breast lesion that has not been managed or treated
- •referred for a breast ultrasound because of a breast mass found on at least one of the following examinations:
- •physical palpation
- •mammography
- •ultrasound exam
排除标准
- •Women who are unwilling or unable to provide informed consent
- •Women with breast implants
- •Women who are pregnant or breastfeeding
- •Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6
- •Women with previous ipsilateral breast surgery
- •Women with no visible breast mass on ultrasound examination
- •Women with axillary metastatic lymph nodes only
- •Women with foreign body in the breast
- •Women who are not Chinese nationality
结局指标
主要结局
Increase in specificity of breast ultrasound imaging when considering stiffness measurements
时间窗: Within 18 months of the study start date
次要结局
- Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements(Within 18 months of the study start date)
- Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements(within 18 months of the study start date)
研究者
研究点 (22)
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