Prospective Trial of Digital Breast Tomosynthesis (DBT) in Breast Cancer Screening.

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.