Review of clinical trials

Clinical trials of full-field digital mammography to date have compared sensitivity, specificity, and receiver operating characteristic (ROC) curves of digital to screen-film mammography, typically in paired studies of the two modalities. The largest study to date has been conducted in women at two institutions in the USA involving 6,736 paired examinations of women aged 40 and over presenting for screening mammography at the University of Colorado and University of Massachusetts Medical Centers. Of 1,467 subjects recommended for additional evaluation on at least one modality, 181 biopsies were performed, yielding detection of 42 cancers. Nine cancers were detected only by digital mammography, 15 only by screen-film mammography, 18 by both, and 8 by neither modality. The difference in cancer detection was not statistically significant (P > 0.1). Digital mammography resulted in fewer recalls than screen-film (799 versus 1,007; P < 0.001). ROC curve areas were 0.74 for digital and 0.80 for screen-film (P > 0.1). Results of other trials conducted to date, primarily diagnostic studies for regulatory approval, will also be described, along with the design of the National Cancer Institute sponsored American College of Radiology Imaging Network (ACRIN) DMIST study of 49,500 women, which is currently underway.