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NOT YET RECRUITING
NCT07841600
NA

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

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

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

OTHER

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.

OTHER

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.