Clinical Evaluation of Dual Mode Tomosynthesis

Clinical performance achieved by adding interpretation of Tomosynthesis images to 2D images (hereinafter 2D+Tomo) was studied. 100 cases who gave written informed consent (ST mode: angular range ±7.5deg, 50 cases and HR mode: ±20deg, 50 cases) were obtained and 7 radiologists interpreted all images. In ST, the sensitivity is significantly increased by 15% (P<.01) and specificity is equivalent (P=.73). In HR, sensitivity of 2D+Tomo against 2D alone is significantly increased by 30% (P<.001) and specificity is significantly decreased by 5% (P<.01). ST, which has higher sensitivity and equivalent specificity, can be used for screening, and HR, which can visualize structures such as lesions in details, can be used for diagnosis. Moreover, specificity enhancement due to inhibition of false positive and sensitivity enhancement are confirmed by trial for appropriate segmentation in Japanese category classification C3. Further detailed clinical performance will be studied such as in ROC analysis with more cases.