Initial clinical evaluation of stationary digital breast tomosynthesis

Full field digital mammography (FFDM) has been the gold standard for mammography. It detects the presence, distribution, and morphology of microcalcifications (MCs), helping predict malignancy. Digital breast tomosynthesis (DBT) has overcome some limitations of FFDM such as poor sensitivity, specificity, and positive predictive values, due to superimposition of tissue, especially in dense breasts. Current DBT systems move an x-ray tube in either continuous (CM), or step-and-shoot motion (SSM). These systems are less effective than FFDM in MC detection due to lower spatial resolution. Motion of the x-ray source and system mechanical instability cause image blur. The image quality is further affected by patient motion due to the relatively long scan time. We developed a stationary DBT (s-DBT) system using a carbon nanotube (CNT) X-ray source array. The CNT array is electronically controlled, rapidly acquiring projection images over a large angular span, with zero tube motion. No source motion, coupled with a large angular span, results in improved in-plane and depth resolution. Using physical phantoms and human specimens, this system demonstrated higher spatial resolution than CM DBT. The objective of this study is to compare the diagnostic clinical performance of s-DBT to that of FFDM. Under UNC's IRB regulations, 100 patients with breast lesions are being recruited and imaged with both modalities. A reader study will compare the diagnostic accuracy of the modalities. We have successfully imaged the first 30 patients. Initial results indicate that s-DBT alone produces comparable MC sharpness, and increased lesion conspicuity compared to FFDM.