Application of strain ultrasonic elastography based on Image Pro Plus software in the diagnosis of Breast Imaging Reporting and Data System category 4 nodules / 肿瘤研究与临床

ABSTRACT

Objective:To explore the diagnostic value of strain ultrasonic elastography (SUE) supported by Image Pro Plus (IPP) software in distinguishing benign and malignant Breast Imaging Reporting and Data System (BI-RADS) category 4 nodules.Methods:The clinical and ultrasound imaging data of 192 female patients with BI-RADS category 4 nodules diagnosed by breast ultrasound in Tianjin Medical University Cancer Institute and Hospital from January 2020 to January 2021 were retrospectively analyzed. One nodule was selected for each patient, and a total of 192 nodules were analyzed. The ultrasound images and SUE images of each nodule were acquired before surgery, followed by BI-RADS classification scoring and SUE scoring. The IPP software was applied to outline the region of interest of all nodules, and the software automatically counted the SUE area ratio (SUE-IPP-AR) of all nodules. Using pathological diagnosis as the gold standard, SUE-IPP scoring was performed based on the optimal cut-off value of SUE-IPP-AR for distinguishing benign and malignant nodules according to receiver operating characteristic (ROC) curve. The efficacy of BI-RADS classification, SUE score, SUE-IPP score, and SUE-IPP+BI-RADS combined score in the differentiation of benign and malignant breast nodules were analyzed by ROC curve. Kappa coefficient was used to assess inter-observer agreement for SUE and SUE-IPP-AR.Results:Of the 192 nodules, 58 were benign nodules and 134 were malignant nodules diagnosed by pathology. These nodules were classified by BI-RADS, with 46 nodules in BI-RADS category 4A, 57 nodules in BI-RADS category 4B and 89 nodules in BI-RADS category 4C. SUE images 1-6 level were 12, 14, 41, 51, 42, and 32 nodules, respectively. ROC curve analysis showed that the optimal cut-off value of SUE-IPP for determining benign and malignant BI-RADS category 4 breast nodules was 58% [area under the curve (AUC) = 0.729, sensitivity 73%, specificity 69%]. The AUC of SUE-IPP+BI-RADS combined score for determining benign and malignant nodules was the largest (0.871), which was higher than that of BI-RADS score (AUC = 0.829, Z = 2.51, P = 0.012), SUE-IPP score (AUC = 0.729, Z = 3.56, P < 0.001) and SUE score (AUC = 0.695, Z = 4.37, P < 0.001). The sensitivity of SUE-IPP+BI-RADS combined score ≥ 3 points for diagnosing malignant nodules was 86.6%, while the specificity was 82.8%. Therefore, SUE-IPP+ BI-RADS score had the best efficacy for determining benign and malignant nodules. There was good agreement between sonographer with more than 5 years of experience and those with less than 5 years of experience in applying SUE to diagnose breast malignant nodules (Kappa = 0.768, 95% CI 0.711-0.825), and very good diagnostic agreement in applying SUE-IPP (Kappa = 0.946, 95% CI 0.919-0.974). Conclusions:SUE-IPP can improve the diagnostic ability for BI-RADS category 4 breast malignant nodules and can be used as an adjunct to ultrasound diagnosis.