ABSTRACT
PURPOSE: To prospectively evaluate the diagnostic contribution of mammography with synchrotron radiation in patients with questionable or suspicious breast abnormalities identified at combined digital mammography (DM) and ultrasonography (US). MATERIALS AND METHODS: The ethics committee approved this prospective study, and written informed consent was obtained from all patients. Mammography with synchrotron radiation was performed with a phase-detection technique at a synchrotron radiation laboratory. Forty-nine women who met at least one of the inclusion criteria (palpable mass, focal asymmetry, architectural distortion, or equivocal or suspicious mass at DM; none clarified at US) were enrolled. Forty-seven women (mean age, 57.8 years ± 8.8 [standard deviation]; age range, 43-78 years) completed the study protocol, which involved biopsy or follow-up for 1 year as the reference standard. Breast Imaging Reporting and Data System (BI-RADS) scores of 1-3 were considered to indicate a negative result, while scores 4-5 were considered to indicate a positive result. The visibility of breast abnormalities and the glandular parenchymal structure at DM and at mammography with synchrotron radiation was compared by using the Wilcoxon signed rank test. RESULTS: In 29 of the 31 patients with a final diagnosis of benign entity, mammography with synchrotron radiation yielded BI-RADS scores of 1-3. In 13 of the remaining 16 patients with a final diagnosis of malignancy, mammography with synchrotron radiation yielded BI-RADS scores of 4-5. Therefore, a sensitivity of 81% (13 of 16 patients) and a specificity of 94% (29 of 31 patients) were achieved with use of the described BI-RADS dichotomization system. CONCLUSION: These study results suggest that mammography with synchrotron radiation can be used to clarify cases of questionable or suspicious breast abnormalities identified at DM. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11100745/-/DC1.