Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,232
- 试验地点
- 5
- 主要终点
- Number of Participants for Whom Study Image Data Were Collected
研究概览
简要总结
This is a case collection study of breast images using standard and new mammography technology.
详细描述
This image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. This study will create a library of image data that will be used for future projects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •For Screening Subjects
- •Be at least 40 years of age, are
- •Asymptomatic,
- •Scheduled for a routine screening mammogram
- •For Recall Subjects
- •Be at least 18 years of age,
- •Received a BIRADS 0 within the last 60 days
- •Are recalled for additional imaging
- •For Diagnostic Subjects
- •Be at least 18 years of age,
- •Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data (BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days.
- •Understand requirements and willing to participate in study
排除标准
- •Presence of a breast implant.
- •Women with only a single breast; for example, post mastectomy patients.
- •Is pregnant or believes she may be pregnant.
- •A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
- •A woman who has significant existing breast trauma within the last one year.
- •Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations.
- •A woman who has had a mammogram performed for the purpose of therapy portal planning within the last year.
- •Cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution.
- •Is an inmate (see US Code of Federal Regulations 45CFR46.306).
结局指标
主要结局
Number of Participants for Whom Study Image Data Were Collected
时间窗: 20 Months
This study created a library of image data to be used in future projects, future product development and regulatory submissions. There was no analysis conducted aside from confirmation of complete images and collected data , as this was merely a collection of images to be used in future reader studies. Sites were provided a target distribution of diagnostic, recall and screening cases to obtain.
次要结局
未报告次要终点