NCT02042456终止不适用
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Abnormal interpretation rate
研究概览
简要总结
This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
- •Women aged ≥18 years at the time of enrollment;*
- •Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
- •At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:
- •AND Referred for screening mammography
排除标准
- •Have been screened using any breast imaging technology in <12 months immediately prior to enrollment;
- •Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
- •Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
- •Are currently pregnant as determined per standard clinical practice at the investigational site;
- •Present with contraindications to any imaging examination required in the study protocol;
- •Have breast implants; OR
- •Are lactating.
结局指标
主要结局
Abnormal interpretation rate
时间窗: One Year
Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).
次要结局
- Sensitivity(One Year)
- Specificity(One Year)
- Cancer Rate(One Year)
- Positive Predictive Value(One Year)
- Negative Predictive Value(One Year)
研究者
研究点 (1)
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