Title:DeepFAN, a transformer-based deep learning model for human-artificial intelligence collaborative assessment of incidental pulmonary nodules in CT scans: a multi-reader, multi-case trial

Abstract:The widespread adoption of CT has notably increased the number of detected lung nodules. However, current deep learning methods for classifying benign and malignant nodules often fail to comprehensively integrate global and local features, and most of them have not been validated through clinical trials. To address this, we developed DeepFAN, a transformer-based model trained on over 10K pathology-confirmed nodules and further conducted a multi-reader, multi-case clinical trial to evaluate its efficacy in assisting junior radiologists. DeepFAN achieved diagnostic area under the curve (AUC) of 0.939 (95% CI 0.930-0.948) on an internal test set and 0.954 (95% CI 0.934-0.973) on the clinical trial dataset involving 400 cases across three independent medical institutions. Explainability analysis indicated higher contributions from global than local features. Twelve readers' average performance significantly improved by 10.9% (95% CI 8.3%-13.5%) in AUC, 10.0% (95% CI 8.9%-11.1%) in accuracy, 7.6% (95% CI 6.1%-9.2%) in sensitivity, and 12.6% (95% CI 10.9%-14.3%) in specificity (P<0.001 for all). Nodule-level inter-reader diagnostic consistency improved from fair to moderate (overall k: 0.313 vs. 0.421; P=0.019). In conclusion, DeepFAN effectively assisted junior radiologists and may help homogenize diagnostic quality and reduce unnecessary follow-up of indeterminate pulmonary nodules. Chinese Clinical Trial Registry: ChiCTR2400084624.