3D Imaging (Tomosynthesis)
Breast tomosynthesis is a new method for breast cancer screening and diagnosis. Unlike prior-generation mammography systems, which generate 2-dimensional images, breast tomosynthesis produces 3-dimensional images that are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density.
In clinical studies Hologic submitted to the FDA, radologists reading 2-dimensional + 3-dimensional mammography (breast tomosynthesis) compared to 2-dimensional mammography alone demonstrated superior clinical performance in specificity, the confidence to rule out breast cancer without recalling the patient for further study, and also demonstrated improved sensitivity, the proportion of mammograms which include breast cancers that were correctly diagnosed. Based on pooled multi-reader receiver operating characteristic (ROC) analysis, Hologic’s clinical trials reviewed by the FDA showed the potential to increase cancer detection by up to 16% and the potential to reduce recall rate by up to 40% when using combo mode (2-dimensional + 3-dimensional breast tomosynthesis) compared with 2-dimensional mammography alone.