Purpose: This study was conducted to assess the clinical impact of breast density and density of the lesion’s background on the performance of a computer-aided detection (CAD) system in the detection of breast masses (MA) and microcalcifications (MC). Materials and Methods: A total of 200 screening mammograms interpreted as BI-RADS 1 and suspicious mammograms of 150 patients having a histologically verified malignancy from 1992 to 2000 were selected by using a sampler of tumor cases. Excluding those cases having more than one lesion or a contralateral malignancy attributable to statistical reasons, 127 cases with 127 malignant findings were analyzed with a CAD system (Second Look 5.0, CADx Systems, Inc., Beavercreek, OH). Of the 127 malignant lesions, 56 presented as MC and 101 presented as MA, including 30 cases with both malignant signs. Overall breast density of the mammogram and density of the lesion’s background were determined by two observers in congruence (density a: entirely fatty, density b: scattered fibroglandular tissue, density c: heterogeneously dense, density d: extremely dense). Results: Within the unsuspicious group, 100/200 cases did not have any CAD MA marks and were therefore truly negative (specificity 50%), and 151/200 cases did not have any CAD MC marks (specificity 75.5%). For these 200 cases, the numbers of marks per image were 0.41 and 0.37 (density a), 0.38 and 0.97 (density b), 0.44 and 0.91 (density c), and 0.58 and 0.68 (density d) for MC and MA marks, respectively (Fisher’s t-test: n.s. for MC, p < 0.05 for MA). Malignant lesions were correctly detected in at least one view by the CAD system for 52/56 (92.8%) MC and 91/101 (90.1%) MA. Detection rate versus breast density was: 4/6 (66.7%) and 18/19 (94.7%) (density a), 32/33 (97.0%) and 49/51 (96.1%) (density b), 14/15 (93.3%) and 23/28 (82.1%) (density c), and 2/2 (100%) and 1/3 (33.3%) (density d) for MC and MA, respectively. Detection rate versus the lesion’s background was: 19/21 (90.5%) and 36/38 (94.7%) (density a), 34/36 (94.4%) and 59/62 (95.2%) (density b), 8/9 (88.9%) and 20/24 (83.3%) (density c), and 9/10 (90%) and 4/8 (50%) (density d) for groups 2 and 3, respectively. Detection rates differed significantly for masses in heterogeneously dense and extremely dense tissue (overall or lesion’s background) versus all other densities (Fisher’s t-test: p < 0.05). A significantly lowered FP rate for masses was found on mammograms of entirely fatty tissue. Conclusion: Overall breast density and density at a lesion’s background do not appear to have a significant effect on CAD sensitivity or specificity for MC. CAD sensitivity for MA may be lowered in cases with heterogeneously and extremely dense breasts, and CAD specificity for MA is highest in cases with extremely fatty breasts. The effects of overall breast density and density of a lesion’s background appear to be similar
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