Patient anxiety and discomfort are considerable during current breast specimen biopsy procedures due to the long time needed to verify lesion removal with existing radiography systems, while poor image quality leads to excess removal of healthy tissue and missed lesions. A faster system with better imaging capability will result in better patient care and improved operating room (OR) efficiency along with reduced costs. The goal of the proposed program is to develop and evaluate a dedicated digital specimen radiography workstation designed for the rapid verification of lesion inclusion in the specimen during surgical and needle core breast biopsies. Based on our experience with electronic imaging systems currently in clinical use for small field stereotactic breast needle biopsy and the results of the Phase I research, this specimen radiography system will produce better image quality than that of conventional film- based specimen radiography systems. The system will enable the surgeon to radiograph and view the specimen in the OR immediately after the excision is made. The system will also have image communication capability for rapid transmission of the specimen image to the radiologist for evaluation. The digital images facilitate various display options as well as greatly simplify archival of data. POTENTIAL COMMERCIAL APPLICATION It is estimated that in the United States 25,000,000 women undergo screening mammography each year. Approximately 2.5% to 3.0% of these patients undergo either surgical or needle biopsy. Of these 625,000 to 750,000 biopsies, only 20% are determined to be malignant. We believe that given the number of biopsy procedures performed each year, in particular the number of biopsies that turn out to be unnecessary, the time savings and increased diagnostic information provided by a digital specimen radiography system would result in significant cost savings and better patient care.
