New Strategies Based on Artificial Intelligence in Breast Cancer Screening Programs in Córdoba With Digital Mammography and Digital Breast Tomosynthesis. A Prospective Evaluation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31,301
- 试验地点
- 2
- 主要终点
- Detection rate
研究概览
简要总结
The use of artificial intelligence software in breast screening (Transpara®) makes it possible to identify studies with a very low probability of cancer.
The hypothesis raised in this work is that reading strategies based on artificial intelligence (single or double reading only of cases with a score> 7 with Transpara®), allow reducing the workload of a screening program by more than 50 % with respect to the standard reading of the program (double reading of all cases without Transpara®), without presenting inferiority in terms of detection rates and recalls of the program, both with the use of 2D digital mammography and with the use of tomosynthesis or 3D mammogram.
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
入排标准
- 年龄范围
- 50 Years 至 71 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women between 50 and 71 years of age (including women who reach that age in the year of appointment), in the Reina Sofía University Hospital district, invited to participate in the Breast Cancer Early Detection Program, that have been randomly assigned in the Hologic equipment (DM or DBT), and who agree to participate in the study by signing the informed consent form.
- •Women studied in the program during the established period and who have previously participated.
- •Women studied in the program for the first time in the established period.
排除标准
- •Women invited to the program who do not agree to participate in the research study by signing the informed consent form.
- •Women with breast prostheses.
- •Women with signs or symptoms of suspected breast cancer.
结局指标
主要结局
Detection rate
时间窗: At the end of the study, at 2 years.
Proportion of women diagnosed with breast cancer among those screened.
Recall or referral rate
时间窗: At the end of the study, at 2 years.
Proportion of women who, after the screening test, are referred to the breast diagnosis unit.
Assessment of Workload of each strategy
时间窗: At the end of the study, at 2 years.
The workload of each strategy shall be assessed by multiplying the average time for a reading of that strategy by the total number of readings of that strategy. The average reading time of a case in each strategy shall be calculated from the measurement of the individual reading time in a sample of 500 cases in each strategy.
次要结局
- Positive predictive value of biopsies(At the end of the study, at 2 years.)
- Positive predictive value of referrals(At the end of the study, at 2 years.)
- Positive predictive value of Transpara® scores(At the end of the study, at 2 years.)