Tomosynthesis Mammography Imaging Screening Trial Lead-in
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,065
- 试验地点
- 8
- 主要终点
- Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
研究概览
简要总结
A randomized screening trial to compare the diagnostic accuracy of screening for breast cancer with three-dimensional digital breast tomosynthesis (DBT) plus two-dimensional full-field digital mammography (FFDM) versus FFDM alone.
详细描述
The Tomosynthesis Mammography Imaging Screening Trial (TMIST) LEAD-IN is being conducted to ensure that all Eastern Cooperative Oncology Group / American College of Radiology Imaging Network (ECOG/ACRIN) TMIST components are properly functional and to provide an opportunity for fine tuning before launching the full TMIST. The accrual target for TMIST LEAD-IN is 6354 participants (one tenth of the projected enrollment target for TMIST) at three lead-in study sites: 1. Sunnybrook Health Sciences Centre in Toronto, 2. Vancouver (under the auspices of the Screening Mammography Programme of British Columbia) and 3. The Ottawa Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Asymptomatic women age 40 and over
- •Scheduled for screening mammogram
- •Able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol
- •Willing and able to provide a written informed consent.
排除标准
- •Presenting for mammography with symptoms of breast disease
- •Have new breast complaints (e.g. lump, nipple discharge)
- •Have had a mammogram of both breasts within the last 11 months
- •Previous personal history of breast cancer
- •Has breast enhancements (e.g. implants or injections)
- •Pregnancy or intent to become pregnant.
结局指标
主要结局
Diagnostic Accuracy of DBT vs FFDM - AUC under ROC comparison
时间窗: 3 year follow-up
To compare the diagnostic accuracy using the area under the curve (AUC) score generated by receiver operator characteristic (ROC) analysis of digital breast tomosynthesis plus full-field digital mammography (DBT) versus full-field digital mammography (FFDM) alone for breast cancer screening. The examinations will be interpreted by local Breast Imaging radiologists. Cancer status will be pathologically confirmed. The women would undergo three consecutive screening rounds in the assigned arm followed by one year of standard of care imaging follow-up.
次要结局
- Recall Rates(3 year)
- Interval Cancers(3 year)
- Prevalence of Breast Cancer Subtypes(3 year)
- Reader Studies of variations of DBT vs FFDM - AUC under ROC comparison(4 year)
- Biomarker Correlation(2 year)
- Clinical Characteristics of Cancers(3 year)
研究者
Dr. Roberta Jong
Principal Investigator
Sunnybrook Health Sciences Centre