AI-Assisted Management of Pulmonary Nodules Found on Low-Dose CT in Health Screening

Pulmonary nodules are frequently found during low-dose computed tomography (LDCT) health screening. The main challenge is not only detecting nodules, but also recommending the appropriate next step, such as routine follow-up, short-interval imaging follow-up, or specialist evaluation. This multicenter cluster-randomized trial will evaluate whether an artificial intelligence (AI)-assisted reporting workflow improves the appropriateness of pulmonary nodule management decisions in health examination settings without increasing under-management or missed referrals. Participating health examination branches, rather than individual participants, will be randomly assigned in a 1:1 ratio to a conventional reporting workflow or an AI-assisted reporting workflow. All final reports will be reviewed and signed by qualified physicians. An independent expert endpoint committee, blinded to study assignment and AI output, will determine the acceptable management range for each case. Approximately 2,000 adults with pulmonary nodules detected on LDCT will be included across at branches.