US-guided diffuse optical tomography for breast lesions: The reliability of clinical experience

Purpose: To prospectively assess the reliability of US-guided diffuse optical tomography (US-DOT) using interobserver agreement for the diagnosis of breast lesions with individual real-time imaging and to assess the interobserver agreement of conventional sonography (US) combined with US-DOT for differentiation between benignity and malignancy breast lesions. Materials and Methods: An Institutional Review Board approved this study, and all subjects provided written informed consent. 122 breast lesions in 111 patients evaluated with US-guided core biopsy were included. Assessments with US and US-DOT for cases subjected to biopsy were obtained by two radiologists using individual real-time imaging prior to biopsy and were prospectively recorded by each performer. With DOT, the total haemoglobin concentration (THC) for each breast lesion was measured. Histopathological results from US-guided biopsies were used as a reference standard. To assess measurement interobserver agreement, the intraclass correlation coefficient (ICC) and the Bland-Altman plot were used for THC in US-DOT and the kappa values and ROC analysis were used to evaluate the diagnostic performances of the US BI-RADS final assessment in US and combined US and US-DOT. Results: Of 122 US-guided core biopsied lesions, 83 (68.0%) were diagnosed as benign, and 39 (32.0%) as malignant. Excellent correlation was seen in the THC in US-DOT (ICC score 0.796; 95% confidence interval, 0.708-0.857). The interobserver agreement in BI-RADS final assessment with US and US-DOT (almost perfect; κ∈=∈0.8618) was improved compared with that of US (substantial agreement, κ∈=∈0.6574). However, the overall areas under the ROC curve did not show significant differences between US and combined US and US-DOT, 0.8894 and 0.8975, respectively (P∈=∈0.981). Conclusions: The reliability of THC in US-DOT showed excellent correlation in overall real-time performance. Although the inter-observer agreement for BI-RADS final assessment of US was improved by using US-DOT, the performances of radiologists with respect to the characterization of breast masses as benign or malignant were not significantly improved with US-DOT.