NCT01928992已完成不适用
A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study
Fujifilm Medical Systems USA, Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Per Breast AUC
研究概览
简要总结
The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Female subjects participating in prior FMSU protocol with known clinical status
排除标准
- •Subjects with unkown clinical status
- •Subjects not truthed in prior FMSU study
结局指标
主要结局
Per Breast AUC
时间窗: 1 Day
Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.
次要结局
- Subject Recall Rate(1 Day)
研究者
研究点 (1)
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