A Multi-center, Controlled, Consecutive Collection of Screening or Diagnostic Full Field Digital Mammography Images Acquired on the Mammomat Novation DR System for Development and Validation of Computer Aided Detection (CAD) Software
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- The study will assess the performance of the MammoDetector™ Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat NovationDR FFDM system compared to conventional film-screen mammography (FSM).
研究概览
简要总结
The study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography.
详细描述
The study design is a controlled study. The study is designed to demonstrate that the performance of the MammoDetector™ Pro on biopsy-proven malignant cases obtained with the Siemens Mammomat NovationDR FFDM system is not inferior to its performance on biopsy-proven malignant cases obtained with conventional film-screen mammography (FSM). The overall sensitivity of the MammoDetector™ Pro with both imaging modalities will be compared. Furthermore, the study is designed to demonstrate that the false marks noted by the MammoDetector™ Pro on routine screening "Normal" cases obtained with the FFDM system is not inferior those marked by the software on routine screening "Normal" cases obtained with conventional film-screen mammography (FSM).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Mammograms obtained from women 40 years of age and over;
- •Mammograms obtained from women only;
- •There are at least four standard views (right cranio-caudal [RCC], right medio-lateral oblique [RMLO], left cranio-caudal [LCC], left medio-lateral oblique [LMLO]) of the breast;
- •Informed consent is obtained.
- •Mammograms of biopsy-proven cancer cases will be considered eligible for inclusion in the study if they meet the following criteria:
- •Biopsy-proven malignant case that was assigned a BI-RADS category 4 or 5 with a suspicious lesion and the corresponding pathology report for the suspicious lesion is available.
- •Cases which have one or more lesion.
- •Routine screening "Normal" cases will be considered eligible for inclusion in the study if they meet the following criteria:
- •The case is a routine screening mammogram assigned a BI-RADS category 1 or 2 by a certified radiologist
排除标准
- •Cases are excluded from the study if they have any of the following conditions:
- •Mammographic needle projection or pre-biopsy markings are evident on the mammogram (these may cause false marks).
- •The mammograms include artifacts created by breast implant.
- •The mammograms are of poor quality (e.g., the digital image has very poor contrast);
- •Mammograms of biopsy-proven cancer cases will be excluded from the study if they have any of the following conditions:
- •Cases in which the lesion is only palpable or visible by another modality (e.g., Ultrasound, MRI).
- •The pathology is not related to a specific region. That is, there is more than one biopsy region and the pathology reports cannot be related to the appropriate mammographic lesion. For example, a mammogram with multiple lesions and multiple related pathology reports on the same date and it is not clear which pathology report belongs to each lesion.
- •The pathology report is more than three months after the FFDM or FSM mammogram.
- •The mammogram was performed for the purpose of planning cancer therapy (e.g., radiation) (BIRADS 6).
- •Cases in which the lesion is characterized as an architectural distortion. -
结局指标
主要结局
The study will assess the performance of the MammoDetector™ Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat NovationDR FFDM system compared to conventional film-screen mammography (FSM).
时间窗: 1 yr
次要结局
未报告次要终点