Deep learning for the detection of benign and malignant pulmonary nodules in non-screening chest CT scans

BACKGROUND: Outside a screening program, early-stage lung cancer is generally diagnosed after the detection of incidental nodules in clinically ordered chest CT scans. Despite the advances in artificial intelligence (AI) systems for lung cancer detection, clinical validation of these systems is lacking in a non-screening setting. METHOD: We developed a deep learning-based AI system and assessed its performance for the detection of actionable benign nodules (requiring follow-up), small lung cancers, and pulmonary metastases in CT scans acquired in two Dutch hospitals (internal and external validation). A panel of five thoracic radiologists labeled all nodules, and two additional radiologists verified the nodule malignancy status and searched for any missed cancers using data from the national Netherlands Cancer Registry. The detection performance was evaluated by measuring the sensitivity at predefined false positive rates on a free receiver operating characteristic curve and was compared with the panel of radiologists. RESULTS: On the external test set (100 scans from 100 patients), the sensitivity of the AI system for detecting benign nodules, primary lung cancers, and metastases is respectively 94.3% (82/87, 95% CI: 88.1-98.8%), 96.9% (31/32, 95% CI: 91.7-100%), and 92.0% (104/113, 95% CI: 88.5-95.5%) at a clinically acceptable operating point of 1 false positive per scan (FP/s). These sensitivities are comparable to or higher than the radiologists, albeit with a slightly higher FP/s (average difference of 0.6). CONCLUSIONS: The AI system reliably detects benign and malignant pulmonary nodules in clinically indicated CT scans and can potentially assist radiologists in this setting.