PMA study for FDA approval of adjunct Digital Breast Tomosynthesis
Wide-angle 2-view DBT plus 2-view FFDM is superior to 2-view FFDM alone for the screening and diagnosis of breast cancer.
|White Paper 0.1 MB|
|PMA studies for FDA approval of adjunct and stand-alone Digital Breast Tomosynthesis||2017|
Wide-angle DBT used in adjunct to FFDM or even as a stand-alone modality shows superior diagnostic accuracy, a reduced non-cancer recall rate, improved reader performance, and lower interobserver variability compared to FFDM alone.
|White Paper 1.9 MB|
Endo et al. “Detectability comparison of modes in dual-mode digital breast tomosynthesis”
AUC increase with the addition of DBT is significantly higher with a wide (40°) rather than a narrow (15°) angle. This is mainly due to the wider angle and not because of e.g. higher dose.
Clauser et al. “Diagnostic performance of digital breast tomosynthesis with a wide scan angle compared to full-field digital mammography for the detection and characterization of microcalcifications”
|2016||Wide scan-angle DBT enables the detection and characterization of microcalcifications with no significant differences from FFDM.||Clinical Study|
Goodsitt et al. “Digital breast tomosynthesis: Studies of the effects of acquisition geometry on contrast-to-noise ratio and observer preference of low-contrast objects in breast phantom images”
|2015||Images acquired with wide tomosynthesis angles have higher CNR and are preferred by readers over those acquired with narrow angles.||Clinical Study|
Dance et al. “Comparison of breast doses for digital tomosynthesis estimated from patient exposures and using PMMA breast phantoms”
|2012||Dose for tomosynthesis with the wide-angle Siemens Mammomat Inspiration system is lower than with systems of other vendors.||Clinical Study|