Abstract

To prospectively investigate the clinical efficacy of using diffuse optical tomography (DOT) and ultrasonographic (US) localization with conventional US to differentiate malignant solid breast lesions from those that are benign. The study was approved by the institutional review board and all patients provided written informed consent. One hundred two consecutive women (mean age, 43 years; range, 18-86 years) who were referred for open biopsy with 136 breast lesions underwent conventional US and DOT with US localization. Total hemoglobin concentration and oxygen saturation were measured for each breast lesion. Sensitivity, specificity, overall accuracy, positive predictive value, and negative predictive value were determined with surgical pathologic examination results as the verification standard. Of the 136 biopsied lesions, 54 were carcinomas and 82 were benign. The average total hemoglobin concentration in the malignant group was 223.3 μmol/L±55.8 (standard deviation), and the average hemoglobin concentration in the benign group was 122.5 μmol/L±80.6 (P=.005). When the maximum hemoglobin concentration of 137.8 μmol/L was used as the threshold value, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of DOT with US localization were 96.3%, 65.9%, 65.0%, 96.4%, and 76.5%, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of conventional US were 96.3%, 92.6%, 89.7%, 97.4%, and 93.4%, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of conventional US combined with DOT were 100%, 93.9%, 91.5%, 100%, and 96.3%, respectively. US-guided DOT combined with conventional US improves accuracy compared with DOT alone.

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