Performance evaluation of digital breast tomosynthesis systems: physical methods and experimental data.

Digital breast tomosynthesis (DBT) has become a well-established breast imaging technique, whose performance has been investigated in many clinical studies, including a number of prospective clinical trials. Results from these studies generally point to non-inferiority in terms of microcalcification detection and superior mass-lesion detection for DBT imaging compared to digital mammography (DM). This modality has become an essential tool in the clinic for assessment and ad-hoc screening but is not yet implemented in most breast screening programmes at a state or national level. While evidence on the clinical utility of DBT has been accumulating, there has also been progress in the development of methods for technical performance assessment and quality control of these imaging systems. DBT is a relatively complicated 'pseudo-3D' modality whose technical assessment poses a number of difficulties. This paper reviews methods for the technical performance assessment of DBT devices, starting at the component level in part one and leading up to discussion of system evaluation with physical test objects in part two. We provide some historical and basic theoretical perspective, often starting from methods developed for DM imaging. Data from a multi-vendor comparison are also included, acquired under the medical physics quality control protocol developed by EUREF and currently being consolidated by a European Federation of Organisations for Medical Physics working group. These data and associated methods can serve as a reference for the development of reference data and provide some context for clinical studies.