Computer-aided detection in direct digital full-field mammography: initial results.

For the first time, full-field digital mammography (FFDM) allows computer-aided detection (CAD) analysis of directly acquired digital image data. The purpose of this study was to evaluate a CAD system in patients with histologically correlated breast cancer depicted with FFDM. Sixty-three cases of histologically proven breast cancer detected with FFDM (Senographe 2000D, GE Medical Systems, Buc, France) were analyzed using a CAD system (Image Checker V2.3, R2 Technology, Los Altos, Calif.). Fourteen of these malignancies were characterized as microcalcifications, 37 as masses, and 12 as both. The mammographic findings were categorized as BI-RADS 3 (n=5), BI-RADS 4 (n=17) and BI-RADS 5 (n=40). The sensitivity for malignant lesions and the rate of false-positive marks per image were calculated. The sensitivity and its 95% confidence interval (CI) were estimated. The sensitivity of the CAD R2 system in breast cancer seen on FFDM was 89% for microcalcifications [CI(95%)=(70%; 98%)] and 81% for masses [CI(95%)=(67%; 91%)]. As expected, the detection rate was higher in lesions categorized as BI-RADS 5 (37 of 40) compared with lesions categorized as BI-RADS 4 (11 of 17). In the group categorized as BI-RADS 3 the detection rate was 4 of 5 lesions; however, this group was very small. The rate of false-positive marks was 0.35 microcalcification marks/image and 0.26 mass marks/image. The overall rate of false-positive marks was 0.61 per image. CAD based on FFDM provides an optimized work flow. Results are equivalent to the results reported for CAD analysis of secondarily digitized image data. Sensitivity for microcalcifications is acceptable and for masses is low. The number of false-positive marks per image should be reduced.