NCT02209129Unknown不适用
3D Digital Breast Tumorsynthesis Versus 2D Digital Mammography in the Clinical Evaluation of Women at High Risk for Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Tumor dectection rate
研究概览
简要总结
Patients with a higher breast cancer risk (higher than 17% according to the IBIS calculation) will receive a 2D digital mammography together with a 3D tomosynthesis (so called combo tomo) of both breasts in two views in order to investigate the additional value of tomosynthesis in the diagnosis of breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •more than 17% risk for breast cancer (IBIS calculation)
- •> 40y old
排除标准
- •< 40y old
结局指标
主要结局
Tumor dectection rate
时间窗: 2 years
The addititional value of 3D tomosythesis to 2D digital mammography will be evaluated by the cancer detection rate, falls negative and falls positive results.
次要结局
- Falls negative, Falls positive results, accuracy(4 years)
研究者
Chantal Van Ongeval, MD, Phd
Prof. dr. Van Ongeval Chantal
Universitaire Ziekenhuizen KU Leuven
研究点 (1)
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