Clinical Trials in Full-Field Digital Mammography

Since the development of the first prototype over a decade ago, full-field digital mammography (FFDM) has been touted as a technically superior way to detect breast cancer compared with screen-film mammography (SFM). Proving technical superiority, however, is easy compared with proving clinical superiority. Whereas the former requires only measurements on phantom images, the latter requires clinical trials to measure the interaction of the technology with real patients and the technologists and radiologists taking care of them. Starting in 1997, four clinical screening trials comparing FFDM with SFM have been conducted. The results of the trials are mixed, but with the publication of the largest and most recent trial, conducted by the American College of Radiology Imaging Network, there are finally statistically significant results showing FFDM to be clinically superior to SFM for specific groups of women.