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NCT07895147

Clinical Application of Artificial Intelligence Methods in Diagnostic Imaging of Pulmonary Nodules

Sponsor: Shanghai East Hospital

View on ClinicalTrials.gov

Summary

This is a retrospective, multicenter observational study evaluating the clinical value of combining high-resolution (1024×1024 matrix) targeted CT scans with an artificial intelligence (AI) deep learning system to distinguish between benign and malignant pulmonary nodules. By analyzing existing medical records and CT images of adult patients (aged 18 and older) with pulmonary nodules (3-30 mm) who have confirmed diagnoses (via postoperative pathology), this study aims to assess the diagnostic accuracy and efficiency of the AI system. The study plans to enroll approximately 10,000 cases from three hospitals in Shanghai. The primary goal is to evaluate the AI system's diagnostic performance (such as sensitivity, specificity, and Area Under the ROC Curve) and compare it with the performance of radiologists, ultimately exploring whether this combined approach can provide more accurate clinical diagnoses and reduce unnecessary procedures.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

10000

Start Date

2026-01-08

Completion Date

2026-12-18

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

OTHER

No intervention

This is a retrospective observational study. No intervention was administered. The AI-assisted diagnostic system was used as an observational assessment tool.

Locations (1)

Shanghai East Hospital (East Hospital Affiliated to Tongji University)

Shanghai, China