Mammography Image Quality Assessment Reading NextGen Images for Screening and Diagnostic Use (MAGNIFI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of Participants With Acceptable Overall Clinical Image Quality
研究概览
简要总结
This study is being conducted to determine the image quality of images using a new investigational medical imaging device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are women aged 40 years or older (≥40 years old);
- •Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
- •Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
- •Are able to walk without assistive devices;
- •Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and
- •Are willing to provide written informed consent to participate.
排除标准
- •Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
- •Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
- •Are currently lactating;
- •Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
- •If enrolled to the DBT (Digital Breast Tomosynthesis) cohort, have breast implants (breast implants are not exclusionary in the FFDM (Full Field Digital Mammography) cohort).
研究组 & 干预措施
Full Field Digital Mammography
2-dimensional breast imaging
干预措施: Full Field Digital Mammography (Device)
Digital Breast Tomosynthesis
3-dimensional breast imaging
干预措施: Digital Breast Tomosynthesis (Device)
结局指标
主要结局
Number of Participants With Acceptable Overall Clinical Image Quality
时间窗: At enrollment completion approximately 3 months post initiation
Overall clinical image quality was assessed by Mammography Quality Standards Act (MQSA) qualified radiologists ("readers"). Readers documented acceptability of FFDM and DBT image quality and image characteristics, as set for in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System (2012).
次要结局
- Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence.(Through study completion, approximately 3 months)