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AI-Assisted Management of Pulmonary Nodules Found on Low-Dose CT in Health Screening
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Summary
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.
Official title: Clinical Utility of Artificial Intelligence-Assisted Management Decisions for Pulmonary Nodules Detected by Low-Dose Computed Tomography in Health Screening: A Multicenter, Prospective, Cluster-Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2026-10-01
Completion Date
2028-12-31
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
AI-Assisted Pulmonary Nodule Reporting Workflow
A locked-version artificial intelligence decision-support workflow applied after the physician records an initial assessment. The system displays pulmonary nodule location, size, density, morphologic features, estimated malignancy risk, and a suggested management category. The physician retains final responsibility. If the system fails, times out, or produces an abnormal output, the case returns to manual reporting. No online learning or automatic model updating is allowed during the trial.
Conventional Pulmonary Nodule Reporting Workflow
Standard manual LDCT interpretation and pulmonary nodule management recommendation by qualified physicians using the participating branch's routine reporting process, without access to study AI output.