Acquisition and Clinical Image Evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 主要终点
- Image Acquisition
研究概览
简要总结
Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.
详细描述
This study is designed to acquire Fujifilm DBT HR mode images and following image acquisition, includes a Clinical Image Evaluation study to assess whether Fujifilm HR DBT images are of sufficiently acceptable quality for use in clinical mammography.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol;
- •Have the ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling;
- •Be female;
- •Be at least 40 years of age;
- •Be asymptomatic; and
- •Have received a final BI-RADS Assessment Category of 1 or 2 (negative or benign findings) on her routine screening mammogram.
排除标准
- •Has a breast implant;
- •Is pregnant or believes she may be pregnant;
- •Has delivered and expressed the intention to breast-feed or is currently breast-feeding;
- •Has significant existing breast trauma with the last one (1) year;
- •Has any breast symptoms (e.g., breast lump, pain, nipple discharge);
- •Has been diagnosed or treated for breast cancer within the last year; or
- •Is an inmate (see US Code of Federal Regulations 45 CFR 46.306).
研究组 & 干预措施
DBT HR mode acquisition with N-mode or H-mode dose
All required imaging for one dose mode will be completed before switching to the other dose mode.
干预措施: DBT HR mode image acquisition (Device)
结局指标
主要结局
Image Acquisition
时间窗: Each study participant will attend a single study visit (acquisition).
To acquire appropriate and sufficient cases to support the Clinical Image Evaluation part of the study.
Clinical Image Evaluation - Image quality
时间窗: Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.
To determine if the DBT HR mode clinical images, when reviewed by expert radiologists, are judged to be of sufficiently acceptable overall clinical image quality for use in clinical mammography.
次要结局
- Clinical Image Evaluation - Pass rating(Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.)
- Image Acquisition - Safety evaluation(Each study participant will attend a single study visit (acquisition).)