Integrated AI Nodule Detection and Diagnosis for Lung Cancer Screening Beyond Size and Growth-Based Standards Compared with Radiologists and Leading Models

arXiv:2512.00281v2 Announce Type: replace-cross
Abstract: Early detection of malignant lung nodules remains limited by reliance on size- and growth-based screening criteria, which can delay diagnosis. We present an integrated AI system that – unlike conventional CADe or CADx approaches – jointly performs nodule detection and malignancy assessment directly at the nodule level from low-dose CT scans within a unified aided decision framework. To address limitations in dataset scale and explainability, we designed an ensemble of shallow deep learning and feature-based specialized models, trained and evaluated on 25,709 scans with 69,449 annotated nodules, with external validation on an independent cohort. The system achieves an area under the receiver operating characteristic curve (AUC) of 0.98 internally and 0.945 on an independent cohort, outperforming radiologists and leading AI models (Sybil, Brock, Google, Kaggle). With a sensitivity of 99.3 percent at 0.5 false positives per scan, it addresses key barriers to AI adoption and demonstrates improved performance relative to both Lung-RADS size-based triage and European volume- and VDT-based screening criteria. The model outperforms radiologists across all nodule sizes and cancer stages – excelling in stage I cancers – and across all growth-based metrics, including volume-doubling time. It also surpasses radiologists by up to one year in diagnosing indeterminate and slow-growing nodules.