Prospective Randomized Trial of Digital Breast Tomosynthesis (DBT) Plus Standard 2D Digital Mammography (2DDM) or Synthetic 2D Digital Mammography (S2D) Compared to Standard 2DDM in Breast Cancer Screening.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- To compare the cost effectiveness of breast cancer screening with digital breast tomosynthesis and 2DDM vs standard screening with 2DDM
研究概览
简要总结
The accuracy of standard two dimension digital mammography (2DDM) in breast cancer screening is limited because of superimposition of normal breast structures onto a two dimensional image. Mammography signs of breast cancer may be obscured, resulting in delay in the diagnosis of breast cancer. Conversely, superimposition of normal tissues may produce features on mammography which are suspicious for cancer and lead to recall for further tests. Digital breast tomosynthesis (DBT) is a new x ray mammography technique which provides three dimensional information to the film reader, overcoming many of the interpretation problems due to tissue superimposition. Studies of DBT + 2DDM in screening have shown increased cancer detection rates and lower false positive recall rates. There may be increased costs related to the technology and reading times.
The aim of this study is to measure the impact and cost effectiveness of DBT + 2DDM in routine screening compared to standard 2DDM.100,000 women wil be recruited using NHS BSP screening sites. At each site, through a clinic randomization process, half of the participants will undergo standard screening with 2DDM (the control group) and half will undergo screening using DBT+2DDM.
详细描述
The accuracy of two view digital x-ray mammography (2DDM), the standard test for breast cancer screening, is limited because of the effect of superimposition of normal breast structures onto a two dimensional image. The mammography signs of breast cancer may be obscured, particularly in women with dense fibro glandular breast tissue, resulting in delay in diagnosis of cancer. National interval cancer data shows that up to 4000 women per annum (2.88 per 1000 screened) are diagnosed with breast cancer in the interval between screens. Conversely, superimposition of normal tissues may produce features on mammography which are suspicious for cancer and lead to unnecessary recall for further diagnostic tests. National screening data for 2012/2013 show that of 2.3 million women screened, 79000 (3.4%) without breast cancer were recalled to specialist diagnostic assessment clinics.
DBT is an x-ray mammography technique which involves acquiring multiple low dose projections over a limited angular range (less than 50 degrees). These projection images are reconstructed into a set of images consisting of parallel planes, typically 1mm apart throughout the breast. Three dimensional information is provided for the reader, overcoming many of the interpretation problems associated with 2DDM. Several studies have demonstrated improvement in the accuracy of DBT in the diagnostic setting. Published data from studies of DBT combined with 2DDM in screening have demonstrated increased rates of invasive cancer detection, cancers detected at a smaller size and decreased false positive recall rates. However, there may be increased costs associated with the technology, image data storage and longer reading time.
As a result of recent technical developments, a two dimensional mammography image can be produced by processing the tomosynthesis image data. Synthetic 2D (S2D) trial data show that the accuracy of DBT + S2D may be the same as that achieved with DBT + 2DDM.
The primary aim of this trial is to assess the impact of the addition of DBT to 2DDM in routine breast cancer screening compared to 2D mammography. 100 000 women will be recruited over twelve months using NHS screening sites with DBT ready mammography equipment. At each site, through a clinic randomisation process, half the trial participants will undergo standard 2DDM (the control group) and half will undergo 2DDM and DBT (the study group). Synthetic 2D images will be produced for all women in the intervention group. A secondary objective of the trial is to compare the accuracy of DBT + 2DDM with DBT + S2D. For each woman in the intervention group, one reader will view DBT + 2DDM, and the other reader will view DBT + S2D. This will enable a non-inferiority test to be applied to DBT + S2D vs DBT + 2DDM.
The investigators plan to use DBT in addition to 2DDM in the intervention group because:
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
- Single (Participant)
盲法说明
participants blinded to type of screening scan
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 50-70 years attending for routine breast cancer screening
排除标准
- •women aged 47-49 and 71-73 invited to participate in the age extension trial
- •women who are unable to give informed consent
结局指标
主要结局
To compare the cost effectiveness of breast cancer screening with digital breast tomosynthesis and 2DDM vs standard screening with 2DDM
时间窗: outcome measures to be reported from 2-7 years following beginning of recruitment into the trial
To compare the effectiveness of breast cancer screening with DBT and 2D mammography with standard 2D mammography screening by measuring the internal cancer rate in women undergoing DBT and 2D mammography VS the interval cancer rate in women undergoing standard 2D mammography. (Estimated interval cancer rates - intervention group 1.85/1000 screened; control group 2.85/1000 screened)
次要结局
未报告次要终点