Digital Breast Tomosynthesis in the Oslo Mammography Screening Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25,000
- 试验地点
- 1
- 主要终点
- Screening performance indicators
研究概览
简要总结
The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program. All women attending the screening unit will be asked if they want to attend the trial. If so, they will be informed about the project, the technique, and the additional compression and radiation dose. All mammographic examinations of women attending the trial will be independently interpreted by four radiologists. Since the trial is part of the official Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out on-line into the national screening database of the NBCSP. The study will include independent reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all examinations having a positive score. Recalls and diagnostic work-up will be according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP.
Outcome measures will use performance indicators for organized screening programs, including recall rate, false positive scores, cancer detection rate, positive predictive values, and cancer characteristics for the individual readers of the trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 69 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 50 to 69 years who have signed the informed consent
排除标准
- •Women with pacemaker, implants, and severely disabled
结局指标
主要结局
Screening performance indicators
时间窗: From Nov. 22, 2010 to Dec. 31, 2012
次要结局
- Interval cancer rate(From Nov. 23, 2010 to Dec. 31, 2014)
研究者
Per Skaane
professor dr. med.
Oslo University Hospital
