Study of Monochromatic X-ray Mammography System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography
研究概览
简要总结
A research study to find out if an investigational mammography machine is effective in producing high-quality images using a lower radiation dose than traditional mammography.
详细描述
Prospective, single-arm, non-blinded, comparative/observational study.
Phase 1: Verify operation of monochromatic system and optimize the monochromatic energies and exposure times for a range of breast thicknesses.
Phase 2: Test the performance of the monochromatic system in comparison to traditional 2-D mammography for a range of clinical/imaging scenarios.
Phase 3: Test the performance of the monochromatic system using reduced breast compression.
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
- 否
入选标准
- •40 yrs of age or older
- •Capable of giving informed consent
- •Prior history of mammography
排除标准
- •Pregnancy
- •History of breast cancer surgery, including lumpectomy or mastectomy
- •Currently undergoing treatment for breast cancer
- •Previous breast augmentations
结局指标
主要结局
Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography
时间窗: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
Demonstrate that a 2-D monochromatic X-ray mammography system can produce mammographic images using lower radiation dose (at least 20% less than conventional mammography), yet, not inferior to conventional mammography. \[Likert scale 1-3. Higher score is a better outcome\]
次要结局
- Relevant pathologies identified by monochromatic-based x-ray as compared to conventional mammography(End of visit 1 (or up to 7 days following visit 1, if needed))
- Lower breast compression with monochromatic-based x-ray mammography(Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed))
- Quality of images produced by monochromatic-based x-ray mammography at lower radiation dose.(Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed))
- Patient satisfaction with monochromatic x-ray mammography system(Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed))