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临床试验/NCT03859492
NCT03859492已完成不适用

Screening Contrast Enhanced Mammography (CEDM) in Intermediate and High-Risk Patient Populations

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 461 人开始时间: 2019年2月15日最近更新:
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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bhavika Patel

Principal Investigator

Mayo Clinic

研究点 (2)

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