Tomosynthesis (TS) Versus Ultrasonography (US) in Screening Women With Dense Breast
试验速览
- 阶段
- 不适用
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- 1) Sensitivity of TS
研究概览
简要总结
Hypothesis The study aims to demonstrate at least equivalence, or non-significant difference between TS and US in women with dense breast screened negative at 2D Mammography.
If the equivalence between TS and US will be demonstrated, US may be substituted by TS with great benefits for the patients and for the healthcare resources.
Aims
- Assess if TS may detect additional cancers in dense breast that approximate US detection capability but with less false positive findings than US.
- If TS detects new cancers in dense breast similarly to US (approximate rate or marginally lower rate), evaluate the the true positive/false positive ratio.
- Cost-analysis. In case of less false positives detected by TS, the true-positive / false positive trade-off might be strongly in favour of TS with a great potential of costs reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic subjects <50 years of age presenting for mammography, with the exception of those that, on previous mammograms are found to have breast density 1-2 according to the Breast Imaging Reporting and Data System (BIRADS D1-2). - Asymptomatic subjects ≥ 50 years of age who request mammography and have breast density BIRADS 3-
- •No history of breast cancer - Written informed consent
排除标准
- •Pregnant and breast feeding women
- •Unable to tolerate breast compression
- •Breast implants
- •Unable to understand or execute written informed consent
- •Unable or unwilling to agree to follow-up during observation period
研究组 & 干预措施
Tomosynthesis
Tomosynthesis will be compared to Ultrasound
干预措施: 3D mammography (Tomosynthesis) (Device)
Ultrasound
Ultrasound (sensitivity and specificity) will be compared to Tomosynthesis
干预措施: Ultrasound (Device)
结局指标
主要结局
1) Sensitivity of TS
时间窗: up to 36 months
We want to verify if TS may detect additional cancers in dense breast that approximate US detection capability but with less false positive findings than US.
次要结局
- 2) Specificity of TS(up to 36 months)
研究者
Alberto Tagliafico
Assistant Professor
University of Genova