Effectiveness and Feasibility of Complementary Lung-RADS Version 1.1 in Risk Stratification for pGGN in LDCT Lung Cancer Screening in a Chinese Population

PURPOSE: To evaluate the effectiveness of using a modified lung imaging reporting and data system (Lung-RADS) for risk stratification of pure ground-glass nodules (pGGNs) in low-dose computed tomography (LDCT) for lung cancer (LC) screenings in China. PATIENTS AND METHODS: Eight subjects with nine pGGNs originating from a Cancer Screening Program were enrolled as training set and 32 asymptomatic subjects with 35 pGGNs were selected as validation set from November 2013 to October 2018. The complementary Lung-RADS categories were set based on the GGN-vessel relationship (GVR). The correlations between GGN-vessel relationships and pathology were evaluated, and the diagnostic value of complementary Lung-RADS version 1.1 in discriminating malignant pGGNs were analyzed. RESULTS: The inter-reader agreements for Lung-RADS 1.1 (intraclass correlation coefficient (ICC= 0.999) and complementary Lung-RADS 1.1 (ICC= 0.971) displayed good reliability. The combined incidence of invasive adenocarcinoma in type III and IV was more than that of benign and preinvasive diseases (30% vs 75%, P=0.013). Type II GVR between two benign (66.7%), seven preinvasive (53.8%), and six invasive (21.4%) GGN cases was statistically significant (χ(2)=5.415, P=0.019). GGN pathological groups and GVR had a significant correlation (r=0.584, P=0.00). Compared to Lung-RADS 1.1, complementary Lung-RADS 1.1 had better performance in the training set, with its sensitivity increased from 33.3% to 88.9%, accuracy increased from 44.4% to 88.9%, false-negative proportion (FNP) decreased from 66.7% to 11.1%, and the sensitivity to predict malignant nodules increased from 13.8% to 93.1%, accuracy increased from 28.6% to 80.0%, and FNP decreased from 86.2% to 6.9% in validation set. The detection rate of preinvasive disease and adenocarcinoma was increased from 12.5% to 90.6% and that of missed diagnosis decreased from 87.5% to 9.4% in the validation set, P=0.004. CONCLUSION: Complementary Lung-RADS 1.1 is superior to Lung-RADS 1.1 and would be beneficial for LC screening of LDCT in China.