Contrast Enhanced 3D Color Amplitude Imaging of the Breasts

In total, 55 patients with 16 cancers and 39 benign lesions were enrolled in the study, which was less than anticipated. Standard 2D ultrasound achieved a sensitivity of 73% and a specificity of 58%, while 3D produced 75% and 36%, respectively. Contrast increased 3D sensitivity to 88% and specificity to 47%. The area under the ROC curve for the detection of breast cancer was 0.55 for 2D contrast, 0.60 for 3D ultrasound and 0.76 for 3D CAI with contrast (p<0.03) . Mammography produced an area of 0.86, which was significantly higher than all ultrasound modalities (p<0.025) except 3D contrast (p=0.16). When mammography was combined with 2D contrast the area increased to 0.88, with 3D contrast to 0.89, and with all ultrasound modalities to 0.96 (p<0.001) . The vascularity and the presence of anastamoses observed with 3D contrast were the only significant markers of malignancy found (p<0.02). In a subset of 17 patients, 2D contrast provided some quantitative parameters, which correlated with direct pathologic vascularity assessments such as the iMVD. Specifically, the microvessel area and density for vessels 30 to 39 micrometers in diameter were most significant. Overall these results validate the fundamental hypothesis of this project; namely that the combination of 3D CAI and an ultrasound contrast agent increases the ability to diagnose breast cancer relative to current techniques.