Diagnostic accuracy of Fischer Senoscan Digital Mammography versus screen-film mammography in a diagnostic mammography population.
RATIONALE AND OBJECTIVES: To compare the diagnostic accuracy of the Fischer Senoscan Digital Mammography System with that of standard screen-film mammography in a population of women presenting for screening or diagnostic mammography. MATERIALS AND METHODS: Enrollment of patients took place at six different breast-imaging centers between 1997 and 1999. A total of 247 cases were selected for inclusion in the final reader study. All known cancer cases were included (111) from all six participating sites representing 45% of the total cases. The remaining 136 cases (55%) were randomly selected from all available benign or negative cases from three of the six sites. A complete case consisted of both a (unilateral or bilateral) digital and screen-film mammogram of the same patient. Eight radiologists interpreted the cases in laser-printed digital and screen-film hardcopy formats. The study was designed to detect differences of 0.05 in the ROC area under the curve (AUC) between digital and screen-film radiologist interpretation performance. RESULTS: The average AUC for the Senoscan digital was 0.715 for the 8 readers. The average AUC for screen-film was 0.765. The difference AUC of -0.05 falls within the 95% confidence interval (-0.101, 0.002). The average sensitivity was 66% and specificity 67% for SenoScan full-field digital mammography. The average screen-film mammography sensitivity and specificity were 74% and 60%, respectively. CONCLUSION: No statistically significant difference in diagnostic accuracy between the Fischer Senoscan and screen-film mammography was detected in this study.
Cole, E; Pisano, ED; Brown, M; Kuzmiak, C; Braeuning, MP; Kim, HH; Jong, R; Walsh, R
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