Abstract
PURPOSE: To evaluate the clinical performance of a hybrid scanner that uses dual-modality tomosynthesis (DMT) and technetium 99m sestamibi to provide coregistered anatomic and functional breast images in three dimensions. MATERIALS AND METHODS: A prospective pilot evaluation of the scanner was performed in women scheduled to undergo breast biopsy after institutional review board approval and informed consent were obtained. All subject data were handled in compliance with the rules and regulations concerning the privacy and security of protected health information under HIPAA. The study included 17 women (mean age, 53 years; age range, 44-67 years) and 21 biopsy-sampled lesions. Results of DMT scanning were compared with histopathologic results for the 21 lesions. RESULTS: Of the 21 lesions, seven were malignant, and 14 were benign. Among the 13 subjects with one lesion each, three had positive biopsy results, and 10 had negative biopsy results. Among the four subjects with two lesions, the biopsy results were as follows: bilateral in one, both negative; bilateral in one, both positive; unilateral in two, one positive and one negative. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of DMT scanning were 86%, 100%, 100%, 93%, and 95%, respectively. CONCLUSION: Pilot clinical evaluation of the DMT scanner suggests that it is a feasible and accurate method with which to detect and diagnose breast cancer. Systems such as the DMT scanner that are designed specifically for three-dimensional multimodality breast imaging could make possible some of the advances in tumor detection, localization, and characterization of breast cancer that are now being observed with whole-body three-dimensional hybrid systems, such as positron emission tomography/computed tomography (CT) or single photon emission computed tomography/CT.