NCT00722059已完成早期 1 期
Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Measure of digital tomosynthesis and digital mammography test performance.
研究概览
简要总结
The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females 30 years of age or older.
- •Dense Breasts.
- •Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
- •Suspicious or palpable mass and scheduled for biopsy.
排除标准
- •Pregnant or lactating women.
- •Prior personal history of breast cancer.
- •Prior breast augmentation with implants or silicon injection. male patients.
- •No two view mammogram as part of breast imaging evaluation.
- •Breast density of almost entirely fatty/scattered fibroglandular densities.
结局指标
主要结局
Measure of digital tomosynthesis and digital mammography test performance.
时间窗: 3 weeks
Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.
次要结局
未报告次要终点
研究者
Alexis V. Nees M.D.
Principal Investigator
University of Michigan
研究点 (2)
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