Low Dose Tomosynthesis Compared to Traditional Tomosynthesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- X-ray dose
研究概览
简要总结
This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.
详细描述
Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images.
The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
This is an imaging study. All participants will be imaged using two modalities. All participant data will be deidentified.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman over 40 years of age
- •Has a tomosynthesis examination with comparator
- •Has a mammographic finding
排除标准
- •Pregnant, breastfeeding or believes she may be pregnant
- •Unable or unwilling to give informed consent
研究组 & 干预措施
Tomo Assessment
Subjects will have a 4-view tomosynthesis examination with the study device.
干预措施: Tomo Assessment (Device)
结局指标
主要结局
X-ray dose
时间窗: 4 months
X-ray dose will be measured per projection.
次要结局
- Lesion conspicuity comparison of images from study device vs comparator(4 months)