A Study to Determine Patient Benefit of Tomosynthesis in Screening Mammography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Interpretation Time of Scan
研究概览
简要总结
Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.
详细描述
We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped < 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines.
- •Prior mammogram report indicating ≥ 25% breast density.
排除标准
- •Prior mammogram report indicating <25% breast density.
- •Breast implants
- •Pregnancy
研究组 & 干预措施
A: routine 2D mammogram
Subject receives regular 2D mammogram.
干预措施: 2D Mammogram (Procedure)
B: Routine Mammogram + tomosynthesis
Routine Mammogram and tomosynthesis
干预措施: Tomosynthesis (Procedure)
结局指标
主要结局
Interpretation Time of Scan
时间窗: Within 1 month of receiving scan
次要结局
- Discomfort Scale(Immediately after the subject receives scan)
- Recall Rates(6 month intervals for 2 years after initial scan)