Performance of Computer-Aided Diagnosis in Ultrasonography for Detection of Breast Lesions Less and More Than 2 cm: Prospective Comparative Study (Preprint)

BACKGROUND Computer-aided diagnosis (CAD) is used as an aid tool by radiologists on breast lesion diagnosis in ultrasonography. Previous studies demonstrated that CAD can improve the diagnosis performance of radiologists. However, the optimal use of CAD on breast lesions according to size (below or above 2 cm) has not been assessed. OBJECTIVE The aim of this study was to compare the performance of different radiologists using CAD to detect breast tumors less and more than 2 cm in size. METHODS We prospectively enrolled 261 consecutive patients (mean age 43 years; age range 17-70 years), including 398 lesions (148 lesions&gt;2 cm, 79 malignant and 69 benign; 250 lesions≤2 cm, 71 malignant and 179 benign) with breast mass as the prominent symptom. One novice radiologist with 1 year of ultrasonography experience and one experienced radiologist with 5 years of ultrasonography experience were each assigned to read the ultrasonography images without CAD, and then again at a second reading while applying the CAD S-Detect. We then compared the diagnostic performance of the readers in the two readings (without and combined with CAD) with breast imaging. The McNemar test for paired data was used for statistical analysis. RESULTS For the novice reader, the area under the receiver operating characteristic curve (AUC) improved from 0.74 (95% CI 0.67-0.82) from the without-CAD mode to 0.88 (95% CI 0.83-0.93; <i>P</i>&lt;.001) at the combined-CAD mode in lesions≤2 cm. For the experienced reader, the AUC improved from 0.84 (95% CI 0.77-0.90) to 0.90 (95% CI 0.86-0.94; <i>P</i>=.002). In lesions&gt;2 cm, the AUC moderately decreased from 0.81 to 0.80 (novice reader) and from 0.90 to 0.82 (experienced reader). The sensitivity of the novice and experienced reader in lesions≤2 cm improved from 61.97% and 73.23% at the without-CAD mode to 90.14% and 97.18% (both <i>P</i>&lt;.001) at the combined-CAD mode, respectively. CONCLUSIONS S-Detect is a feasible diagnostic tool that can improve the sensitivity for both novice and experienced readers, while also improving the negative predictive value and AUC for lesions≤2 cm, demonstrating important application value in the clinical diagnosis of breast cancer. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1800019649; http://www.chictr.org.cn/showprojen.aspx?proj=33094