Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,069
- 试验地点
- 8
- 主要终点
- determine the benefit of tomosynthesis for diagnosis
研究概览
简要总结
This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly
- •age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)
- •breast size suitable for detector size
- •possible prior mastectomy
- •security social covered
- •signed informed consent
排除标准
- •breast implant
- •high genetic risk (mutation)
- •under justice measures
- •breast feeding or pregnant woman
研究组 & 干预措施
breast cancer histologically proven
Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment
干预措施: tomosynthesis (Device)
breast cancer histologically proven
Patient with breast cancer histologically proven, addressed to Oscar Lambret Center for treatment
干预措施: 2D mammography (Device)
surveillance of a treated breast cancer
surveillance of patient already treated for breast cancer must have annual mammography
干预措施: tomosynthesis (Device)
surveillance of a treated breast cancer
surveillance of patient already treated for breast cancer must have annual mammography
干预措施: 2D mammography (Device)
diagnosis of a detected anomaly
patient addressed for diagnosis of a detected anomaly
干预措施: tomosynthesis (Device)
diagnosis of a detected anomaly
patient addressed for diagnosis of a detected anomaly
干预措施: 2D mammography (Device)
结局指标
主要结局
determine the benefit of tomosynthesis for diagnosis
时间窗: 30 months
number of avoided focused cliches and ultrasound, after tomosynthesis analysis
次要结局
- measurement of breast irradiation(30 months)
- number of additional cancer detected by tomosynthesis(30 months)
- determine best incidence of realization(30 months)
- evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast(30 months)