NCT00535184已完成不适用
A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 3. Women Undergoing Breast Biopsy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
研究概览
简要总结
Comparison of the ability of DBT and FFDM to detect breast cancer.
详细描述
Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and diagnostic mammography) must have been conducted on GE equipment and the images must be available (or imaging must be repeated). DBT images will be read on-site by one or more qualified radiologists. All subjects who undergo biopsy will be asked to return in approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by independent readers.
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
- 否
入选标准
- •Women ≥18 years or older and has underwent screening/diagnostic mammography and referred for breast biopsy
- •Able and willing to comply with study procedures, and have signed and dated the informed consent form
- •Surgically sterile or postmenopausal
排除标准
- •Pregnant or trying to become pregnant
- •Has signs or symptoms of breast cancer
- •Has been previously included in this study
- •Has breast implants
- •Has a history of breast cancer and is in active treatment
- •Has breasts too large to be adequately positioned for the DBT examination
研究者
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