In Breast Cancer Detection, the Evidence Points to Tomosynthesis

Tomosynthesis is going from strength to strength. Several recently published clinical studies demonstrate that screening with Hologic tomosynthesis in combination with conventional 2D imaging results in higher detection rates ^(i-iii)

and lower false-positive rates.⁽ⁱⁱⁱ⁾

Results of the first large-scale, prospective clinical study on breast tomosynthesis were published in April 2013 in the scientific journal Radiology. The study, “Comparison of Digital Mammography Alone and Digital Mammography plus Tomosynthesis in a Population-based Screening Program” was led by Per Skaane, M.D., Ph.D. from Oslo University Hospital Ullevaal. Well-respected in his field, Skaane and his research team conducted the previous Oslo I and Oslo II trials comparing digital mammography to screen-film for the detection of breast cancer.

• A 40% increase in the detection of invasive breast cancers
  
• A 27% increase in the detection of all cancers (invasive and in situ cancers combined)
• A 15% decrease in false-positive rates
  

The authors reported that the increase in cancer detection was found across all breast tissue densities, from dense to fatty.

Another European study, "Integration of 3D digital mammography with tomosynthesis for population breast-cancer screening (STORM): a prospective comparison study," came to a similar conclusion. The study, led by a team of Italian and Australian researchers represented by Associate Professor Nehmat Houssami, at the University of Sydney's School of Public Health in Australia, was published in June 2013 in Lancet Oncology.

The study, "Implementation of Breast Tomosynthesis in a Routine Screening Practice: An Observational Study", compared breast cancer screening with Hologic’s breast tomosynthesis to conventional 2D mammography alone and showed a significant reduction in recall rates and a sizeable increase in cancer detection, particularly invasive cancer, across all breast tissue densities.

The Rose study found that the use of Hologic's breast tomosynthesis resulted in:

A lower-dose tomosynthesis option from Hologic, the C-View software option, has been commercially available in Europe and many countries in Latin America and Asia since 2011 and became available in the US in May 2013. Hologic's C-View software produces 2D images from 3D datasets. These generated 2D images may now be used in place of the conventional 2D exposure required by the US Food and Drug Administration (FDA) as part of a Hologic 3D mammography screening exam. The combination of Hologic's 3D and C-View 2D images results in a faster combined exam scan time (about 4 seconds) resulting in less time under compression for greater patient comfort and reduced risk of motion. While Hologic 3D mammography is well under the MQSA and EUREF limits and deemed safe, the 3D and C-View exam offers lower patient radiation dose compared to combo mode. In fact, 3D mammography procedures with C-View offers a total patient dose similar to a 2D only exam while providing superior clinical performance for all breast types.

Another important advance in breast tomosynthesis is the ability to perform a breast biopsy using tomosynthesis guidance. The Hologic Affirm™ breast biopsy guidance system, combined with a Selenia® Dimensions® breast tomosynthesis system and the Eviva® breast biopsy device are being used in increasing numbers in Europe and the U.S. for this purpose. The Affirm tomosynthesis biopsy procedure allows the localisation and accurate targeting of regions of interest and is especially important for targeting lesions not found in 2D images or in other modalities. This new biopsy technique has numerous advantages over traditional stereotactic biopsy procedures, including faster lesion targeting, lower patient dose and reduced patient procedure time.