Lung-RADS Version 1.0 versus Lung-RADS Version 1.1: Comparison of Categories Using Nodules from the National Lung Screening Trial.

Background The American College of Radiology updated Lung Imaging Reporting and Data System (Lung-RADS) version 1.0 to version 1.1 in May 2019, with the two key changes involving perifissural nodules (PFNs) and ground-glass nodules (GGNs) now designated as a negative screening result. This study examines the effects of these changes using National Lung Screening Trial (NLST) data. Purpose To determine the frequency of PFNs and GGNs reclassified from category 3 or 4A to the more benign category 2 in the updated Lung-RADS version 1.1, as compared with Lung-RADS version 1.0, using CT scans from the NLST. Materials and Methods In this secondary analysis of the NLST, the authors studied all noncalcified nodules (NCNs) found on the incident scan. Nodules were evaluated using criteria from both Lung-RADS version 1.0 and version 1.1, which were compared to determine changes in the number of nodules deemed benign. A McNemar test was used to assess statistical significance. Results A total of 2813 patients (mean age ± standard deviation, 62 years ± 5; 1717 men) with 4408 NCNs were studied. Of the largest 1092 solid NCNs measuring at least 6 mm but less than 10 mm, 216 (19.8%) were deemed PFNs (category 2) using Lung-RADS version 1.1. Eleven of the 1092 solid NCNs (1.0%) were malignant, but none were PFNs. Of 161 GGNs, three (1.9%) were category 3 according to Lung-RADS version 1.0, of which two (66.7%) were down-classified to category 2 with version 1.1. One of the three down-categorized GGNs (version 1.1) proved to be malignant (false-negative finding). Statistically significant improvement for Lung-RADS version 1.1 was found for total nodules (P < .01) and PFNs (P < .01), but not GGNs (P = .48). Conclusion This secondary analysis of National Lung Screening Trial data shows that Lung Imaging Reporting and Data System version 1.1 decreased the number of false-positive results. This was related to the down-classification of perifissural nodules in the range of 6 up to 10 mm. The increase in allowable nodule size for ground-glass nodules in category 2 from 20 mm (version 1.0) to 30 mm (version 1.1) showed no benefit. © RSNA, 2021 See also the editorial by Mayo and Lam in this issue.