NCT03859492已完成不适用
Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 461
- 试验地点
- 2
- 主要终点
- Breast Cancer
研究概览
简要总结
This research study is being done to determine if Contrast Enhanced Digital Mammography (CEDM) can improve breast cancer detection and can be used as an additional screening method to the standard mammographic screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 35 and had a negative routine mammogram within 6 months.
- •Qualifies as intermediate or high-risk (>15% lifetime risk of breast cancer as defined by IBIS version 8).
排除标准
- •Known breast cancer
- •Previously had negative MBI or MRI within 12 months of study
- •Pregnant or lactating
- •Contraindication to intravenous iodinated contrast
- •Unable to understand or sign informed consent
- •Self-reported signs or symptoms of breast cancer
结局指标
主要结局
Breast Cancer
时间窗: 3 years
Number of subjects diagnosed with breast cancer
次要结局
未报告次要终点
研究者
Bhavika Patel
Principal Investigator
Mayo Clinic
研究点 (2)
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