As long as breast cancer remains a pervasive health concern, the need for ever-improving breast cancer imaging technology will exist. Design changes to incorporate new hardware technologies or methods may trigger the need for clinical trials to ensure device safety and assess performance. Conducting a clinical trial is not only expensive, but often takes years for patient recruitment and study. Utilizing physical phantoms, rather than patients, would be faster, far less expensive, reduce risk to patients and potentially increase the speed with which life-saving technological advances are made available to the public. Because currently available compressed and uncompressed breast phantoms are not real breast images, the users do not have this option. Utilizing our unique access to a large data set (over 1100) of three-dimensional real patient breast images and a novel approach to phantom development, we propose to fill this need. We propose a two-step process for the design, fabrication and evaluation of a collection of realistic anthropomorphic breast phantoms. From our large image data set we will generate the digital and physical phantoms for a series of phantoms spanning different breast shape, size, density and glandular distribution. Our product will be available to manufacturers, hospitals and researchers.
