Clinical trial · Interventional
AI-Assisted Management of Pulmonary Nodules Found on Low-Dose CT in Health Screening
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Decision Support | — | UNRESOLVED | — |
| Pulmonary Nodule | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-Assisted Pulmonary Nodule Reporting Workflow | Other | — | UNRESOLVED |
| Conventional Pulmonary Nodule Reporting Workflow | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AI-Assisted Pulmonary Nodule Reporting Workflow
- description
- Physicians first record and lock an initial pulmonary nodule management decision without viewing AI results. They then review locked-version AI outputs, including nodule characteristics, estimated malignancy risk, and a management recommendation, and issue the final physician-signed report. Physicians may accept, modify, or reject the AI recommendation. The AI cannot automatically sign reports or directly instruct participants.
- interventionNames
- Other: AI-Assisted Pulmonary Nodule Reporting Workflow
- type
- ACTIVE_COMPARATOR
- label
- Conventional Pulmonary Nodule Reporting Workflow
- description
- Physicians interpret LDCT examinations and issue pulmonary nodule management recommendations using the participating branch's conventional clinical reporting workflow. Study AI output is not displayed.
- interventionNames
- Other: Conventional Pulmonary Nodule Reporting Workflow
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older. * Undergoing chest low-dose computed tomography at a participating health examination branch during the study recruitment period. * At least one pulmonary nodule is identified on the index LDCT and requires risk stratification and a management decision regarding follow-up, repeat imaging, or specialist evaluation. * Thin-section reconstructed images are of sufficient quality for clinical interpretation and, where applicable, AI analysis. * Required clinical risk information is available, including age, sex, smoking history, history of malignancy, family history of lung cancer, and available prior chest imaging. * Included under the ethics committee-approved consent, simplified notification, waiver, and/or opt-out process, with no documented refusal of research data use. Exclusion Criteria: * Previously diagnosed lung cancer or currently receiving lung cancer-related treatment. * Known pulmonary metastasis from another malignancy. * Imaging findings that clearly require immediate entry into a lung cancer specialty diagnostic or treatment pathway and are not appropriate for routine pulmonary nodule risk-stratified management. * An urgent thoracic condition requiring immediate management, such as pneumothorax, large pleural effusion, or acute pulmonary embolism. * Severe imaging artifact, incompatible slice thickness or reconstruction, or a lesion type, imaging parameter, or disease extent outside the prespecified locked scope of the AI system. * Previous enrollment in this study. * Explicit refusal of research data use, or another reason judged by the investigator to make inclusion inappropriate.
References
Publications (0)
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