NCT07841600Not yet recruiting
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 · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 20 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Mar 2028
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07841600
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From Oct 2026 to the primary completion date, Mar 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed lung cancer or currently receiving lung cancer-related treatment.
- Previous enrollment in this study.
Other illness
- 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.
Other
- Explicit refusal of research data use, or another reason judged by the investigator to make inclusion inappropriate.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.