Tomosynthesis (TS) or Ultrasound (US) in Mammography-negative Dense Breasts (TOMUS). National Multicenter Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Incremental Cancer Detection Rate or Area Under the Curve
研究概览
简要总结
Breast cancer remains a worldwide big killer with a rate of deaths compared with newly diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer. Mammography is established as the primary investigation for population-based breast cancer screening. Advances in mammographic technique regarding both hardware and software applications are still not sufficient to overcome mammography's limitation with regard to both sensitivity and specificity. Depending on several factors, such as age and breast density, mammography screening is associated with a false-negative rate of 10-20 %.
Digital Breast Tomosynthesis (TS) is a novel technique that is able to study the breast using 3D reconstructions of the tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle. This process aims at a increasing the number of lesion visible due to the reduction of overlapping breast tissue.
In TS, to overcome these limitations, a digital mammography (DM) unit is modified to allow the X-ray tube to move through a proscribed arc of excursion acquiring a fixed number of discrete projection images while the breast remains in compression. The individual projection images are extremely low in dose, so the composite dose incurred during a TS acquisition may be similar to that of a standard 2D mammography. The radiologically dense breasts are associated with decreased sensitivity of mammography, both in the clinical and screening setting as well as its established association with breast cancer risk. The systematic application of ultrasound (US) in women with radiologically dense breasts and negative mammogram has been shown to be associated with an additional cancer detection rate [7,8,9]. Incremental ultrasound detection of cancer may be considered in the range of 0.27% to 0.52% of ultrasound-screened women in different density categories [10]. In addition, the main limitation of US in breast screening is represented by false- positive findings. These findings result in additional investigation or unnecessary surgical biopsy [10].
详细描述
Breast cancer remains a worldwide big killer with a rate of deaths compared with newly diagnosed cases not lower than 20%. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer. Mammography is established as the primary investigation for population-based breast cancer screening. Advances in mammographic technique regarding both hardware and software applications are still not sufficient to overcome mammography's limitation with regard to both sensitivity and specificity. Depending on several factors, such as age and breast density, mammography screening is associated with a false-negative rate of 10-20 %.
Digital Breast Tomosynthesis (TS) is a novel technique that is able to study the breast using 3D reconstructions of the tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle. This process aims at a increasing the number of lesion visible due to the reduction of overlapping breast tissue.
In TS, to overcome these limitations, a digital mammography (DM) unit is modified to allow the X-ray tube to move through a proscribed arc of excursion acquiring a fixed number of discrete projection images while the breast remains in compression. The individual projection images are extremely low in dose, so the composite dose incurred during a TS acquisition may be similar to that of a standard 2D mammography. The radiologically dense breasts are associated with decreased sensitivity of mammography, both in the clinical and screening setting as well as its established association with breast cancer risk. The systematic application of ultrasound (US) in women with radiologically dense breasts and negative mammogram has been shown to be associated with an additional cancer detection rate. Incremental ultrasound detection of cancer may be considered in the range of 0.27% to 0.52% of ultrasound-screened women in different density categories [10]. In addition, the main limitation of US in breast screening is represented by false- positive findings. These findings result in additional investigation or unnecessary surgical biopsy.
The study aims to demonstrate at least statistical equivalence, or non-significant difference between TS and US in women with dense breasts.
If the equivalence between TS and US will be demonstrated, US may be substituted by TS with great benefits for the patients and for the healthcare resources we aim to:
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic subjects <50 years of age presenting for mammography, with the exception of those that, on previous mammograms are found to have breast density BI- RADS D1-
- •Asymptomatic subjects ≥ 50 years of age who request mammography and have breast density BI-RADS 3-
- •Written Informed consent.
排除标准
- •Pregnant and breast feeding women
- •Unable to tolerate breast compression
- •Breast implants
- •Unable to understand or execute written informed consent
- •Unable or unwilling to agree to follow-up during observation period
结局指标
主要结局
Incremental Cancer Detection Rate or Area Under the Curve
时间窗: 2 years
The study aims to demonstrate at least statistical equivalence, or non-significant difference between TS and US in women with dense breasts.
次要结局
- TP/FP rate(2 years)
研究者
Alberto Tagliafico
Assistant Professor
University of Genova