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Accuracy of Soft-Copy Digital Mammography versus That of Screen-Film Mammography according to Digital Manufacturer: ACRIN DMIST Retrospective Multireader Study¹

¹ From the Lynn Sage Comprehensive Breast Ctr and Dept of Radiology, Feinberg School of Medicine, Northwestern Univ, Galter Pavilion, 13th Floor, 251 E Huron St, Chicago, IL 60611 (R.E.H.); Dept of Radiology, Univ of North Carolina School of Medicine, Chapel Hill, NC (E.B.C., E.D.P.); Ctr for Statistical Sciences, Brown Univ, Providence, RI (S.A., H.M., C.G.); Dept of Radiology, Univ of Virginia, Charlottesville, Va (M.A.C.); Dept of Medical Imaging and Medical Biophysics, Univ of Toronto, Toronto, Ontario, Canada (R.A.J., G.E.M.); Dept of Radiology, Univ of Washington, Seattle, Wash (K.M.K.); Dept of Radiology, Emory Univ, Atlanta, Ga (C.J.D.); and Dept of Radiology, William Beaumont Hosp, Royal Oak, Mich (M.R.). All members of the DMIST Investigators Group are listed in the Appendix. R.E.H. has received honoraria from GE Healthcare for continuing medical education lectures. The Univ of North Carolina has research agreements with GE from which E.B.C. receives some salary support. R.A.J. has a current research collaboration with GE Healthcare involving digital mammography. C.J.D. is a medical consultant with GE Medical and Hologic and a stockholder with Hologic. Received Mar 2, 2007; revision requested May 2; revision received Aug 16; accepted Aug 28; final version accepted Sept 26. Address correspondence to R.E.H. (e-mail: edward.hendrick{at}gmail.com).

Purpose: To retrospectively compare the accuracy for cancer diagnosis of digital mammography with soft-copy interpretation with that of screen-film mammography for each digital equipment manufacturer, by using results of biopsy and follow-up as the reference standard.

Materials and Methods: The primary HIPAA-compliant Digital Mammographic Imaging Screening Trial (DMIST) was approved by the institutional review board of each study site, and informed consent was obtained. The approvals and consent included use of data for future HIPAA-compliant retrospective research. The American College of Radiology Imaging Network DMIST collected screening mammography studies performed by using both digital and screen-film mammography in 49 528 women (mean age, 54.6 years; range, 19–92 years). Digital mammography systems from four manufacturers (Fischer, Fuji, GE, and Hologic) were used. For each digital manufacturer, a cancer-enriched reader set of women screened with both digital and screen-film mammography in DMIST was constructed. Each reader set contained all cancer-containing studies known for each digital manufacturer at the time of reader set selection, together with a subset of negative and benign studies. For each reader set, six or 12 experienced radiologists attended two randomly ordered reading sessions 6 weeks apart. Each radiologist identified suspicious findings and rated suspicion of breast cancer in identified lesions by using a seven-point scale. Results were analyzed according to digital manufacturer by using areas under the receiver operating characteristic curve (AUCs), sensitivity, and specificity for soft-copy digital and screen-film mammography. Results for Hologic digital are not presented owing to the fact that few cancer cases were available. The implemented design provided 80% power to detect average AUC differences of 0.09, 0.08, and 0.06 for Fischer, Fuji, and GE, respectively.

Results: No significant difference in AUC, sensitivity, or specificity was found between Fischer, Fuji, and GE soft-copy digital and screen-film mammography. Large reader variations occurred with each modality.

Conclusion: No statistically significant differences were found between soft-copy digital and screen-film mammography for Fischer, Fuji, and GE digital mammography equipment.

© RSNA, 2008