ABSTRACT

Due to the complexity of clinical breast cancer imaging systems, their validation and optimization are challenging tasks, which require both preclinical and clinical studies. ™is is particularly true for systems used in breast cancer screening due to the low prevalence of disease in a screening population. Validation for screening requires clinical trials involving very large numbers of volunteers and repeated imaging using di›erent acquisition conditions. ™is results in delayed dissemination of new technology due to the prohibitive duration and cost of such trials, increased radiation risk in the case of imaging systems utilizing ionizing radiation, and strict limitations on the number of test conditions.