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.