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NCT07895147Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
10000 (estimated)
First submitted
13 Oct 2026
Start date
8 Jan 2026
Primary completion date
6 Oct 2026
Lead sponsor
Shanghai East Hospital
Diseases
Lung cancer
NCT number
NCT07895147

What you commit to

  • Study type: Observational
  • Planned participants: 10000
  • From 8 Jan 2026 to the primary completion date, 6 Oct 2026
  • 1 site in 1 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

  • History of ipsilateral lung malignancy or prior local treatments (e.g., radiotherapy, ablation) to the lung.

Other

  • Severe motion artifacts or noise on CT images affecting image quality and diagnostic assessment.
  • Pregnant or lactating women.
  • Incomplete clinical data or loss to follow-up.

Who the study is looking for

  • Age ≥ 18 years.
  • Pulmonary nodules (diameter ≥ 3 mm and ≤ 30 mm) detected by high-resolution targeted CT scan.
  • Confirmed pathological diagnosis benign or malignant (gold standard).
  • Complete imaging data, including scan slice thickness 1 mm, and images with a 1024×1024 scan matrix.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shanghai East Hospital (East Hospital Affiliated to Tongji University)
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.