Evaluation of the Quadri-Planes Method in Computer-Aided Diagnosis of Breast Lesions by Ultrasonography: Prospective Single-Center Study

Background Computer-aided diagnosis (CAD) is a tool that can help radiologists diagnose breast lesions by ultrasonography. Previous studies have demonstrated that CAD can help reduce the incidence of missed diagnoses by radiologists. However, the optimal method to apply CAD to breast lesions using diagnostic planes has not been assessed. Objective The aim of this study was to compare the performance of radiologists with different levels of experience when using CAD with the quadri-planes method to detect breast tumors. Methods From November 2018 to October 2019, we enrolled patients in the study who had a breast mass as their most prominent symptom. We assigned 2 ultrasound radiologists (with 1 and 5 years of experience, respectively) to read breast ultrasonography images without CAD and then to perform a second reading while applying CAD with the quadri-planes method. We then compared the diagnostic performance of the readers for the 2 readings (without and with CAD). The McNemar test for paired data was used for statistical analysis. Results A total of 331 patients were included in this study (mean age 43.88 years, range 17-70, SD 12.10), including 512 lesions (mean diameter 1.85 centimeters, SD 1.19; range 0.26-9.5); 200/512 (39.1%) were malignant, and 312/512 (60.9%) were benign. For CAD, the area under the receiver operating characteristic curve (AUC) improved significantly from 0.76 (95% CI 0.71-0.79) with the cross-planes method to 0.84 (95% CI 0.80-0.88; P<.001) with the quadri-planes method. For the novice reader, the AUC significantly improved from 0.73 (95% CI 0.69-0.78) for the without-CAD mode to 0.83 (95% CI 0.80-0.87; P<.001) for the combined-CAD mode with the quadri-planes method. For the experienced reader, the AUC improved from 0.85 (95% CI 0.81-0.88) to 0.87 (95% CI 0.84-0.91; P=.15). The kappa indicating consistency between the experienced reader and the novice reader for the combined-CAD mode was 0.63. For the novice reader, the sensitivity significantly improved from 60.0% for the without-CAD mode to 79.0% for the combined-CAD mode (P=.004). The specificity, negative predictive value, positive predictive value, and accuracy improved from 84.9% to 87.8% (P=.53), 76.8% to 86.7% (P=.07), 71.9% to 80.6% (P=.13), and 75.2% to 84.4% (P=.12), respectively. For the experienced reader, the sensitivity improved significantly from 76.0% for the without-CAD mode to 87.0% for the combined-CAD mode (P=.045). The NPV and accuracy moderately improved from 85.8% and 86.3% to 91.0% (P=.27) and 87.0% (P=.84), respectively. The specificity and positive predictive value decreased from 87.4% to 81.3% (P=.25) and from 87.2% to 93.0% (P=.16), respectively. Conclusions S-Detect is a feasible diagnostic tool that can improve the sensitivity, accuracy, and AUC of the quadri-planes method for both novice and experienced readers while also improving the specificity for the novice reader. It demonstrates important application value in the clinical diagnosis of breast cancer. Trial Registration ChiCTR.org.cn 1800019649; http://www.chictr.org.cn/showproj.aspx?proj=33094