NCT01963624已完成不适用
Multicenter Prospective Study to Evaluate the Value of Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,241
- 试验地点
- 10
- 主要终点
- Positive predictive value of breast screening with US
研究概览
简要总结
The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.
详细描述
- Asymptomatic women who undergo breast screening with ultrasound and has breast masses of Breast Imaging Reporting and Data System (BI-RADS) category 3 or higher will be examined with conventional B-mode US as well as combined elasto-doppler US by breast radiologists.
- The likelihood of malignancy and BI-RADS category of the breast masses are assessed for each dataset of B-mode US alone and B-mode US with elasto-doppler US, respectively.
- Reference standard: Biopsy or 1 year of follow-up examination.
- The positive-predictive value, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) are evaluated and compared between B-mode US alone and B-mode US with elasto-doppler US.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 30 years or older screened with breast ultrasound without specific symptoms
- •Women who underwent mammography within 3 months which showed no abnormality except for dense breast
- •Women who had at least one breast mass of BI-RADS category 3 or higher.
排除标准
- •Women with breast implants
- •Women who are unwilling or unable to provide informed consent
- •Lesions larger than 3 cm
- •Lesions that are previously noted and followed-up in the same hospital
结局指标
主要结局
Positive predictive value of breast screening with US
时间窗: 1 year after enrollment
Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.
次要结局
- Sensitivity(1 year after enrollment)
- Specificity(1 year after enrollment)
- Diagnostic accuracy(1 year after enrollment)
研究者
Woo Kyung Moon
Professor
Seoul National University Hospital
研究点 (10)
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