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OpenTrials
Completed

NCT Number: NCT07000721

Research on New Diagnosis and Treatment Technologies for Early Lung Cancer

To verify the clinical effectiveness and safety of the airway tree navigation system constructed by artificial intelligence (AI) in the navigation diagnosis of peripheral pulmonary nodules (PPLs).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

About this study

Early diagnosis and treatment of lung cancer is of great significance, in which navigated tracheoscopic biopsy is an important tool for confirming the diagnosis of early lung cancer. Conventional navigation software realizes airway reconstruction and guides biopsy by recognizing differences in HU values on computed tomography scans. It is difficult for conventional navigation software to recognize the reconstruction due to the special characteristics of small airways that are susceptible to interference and collapse. Therefore, an AI deep learning approach can realize accurate construction of small airways and guide accurate biopsy. This study intends to validate the clinical effectiveness and safety of the AI-constructed airway tree navigation system in the navigational diagnosis of peripheral pulmonary nodules (PPLs).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or above.
  • Patients with one or more peripheral lung nodules suspected to be lung cancer or poorly absorbing lesions on conventional anti-infective therapy.
  • Patients with nodule diameters ≤30 mm (diameters mentioned in the text are the average of the maximum and minimum diameters).
  • The nodules were pure ground glass nodules, partially solid nodules, or solid nodules.
  • The nodule is surrounded by lung parenchyma and is not visible in the bronchial lumen above the segment.

Exclusion criteria

  • Preoperative judgment that it is difficult for the patient to benefit from bronchoscopic biopsy (e.g., high risk of bleeding due to perivascular encasement of the lesion, difficulty in reaching the airway adjacent to the lesion due to previous lung surgery, etc.).
  • Those with incomplete clinical data.
  • Those with missing visits after biopsy.

Treatment and study plan

Preoperative navigation path planning using the SARS-pro navigation system

Diagnostic Test

The SARS-pro navigation system was used for preoperative navigation path planning for tracheoscopic biopsies in the new navigation system group (patients with suspected lung cancer).

Preoperative navigation path planning using the VBN navigation system

Diagnostic Test

The VBN navigation system was used for preoperative navigation path planning for tracheoscopic biopsies in the old navigation system group (patients with suspected lung cancer).

Primary outcomes

  1. Diagnostic positive yield

    Time frame: One month after the patients were enrolled

    After biopsy by navigational bronchoscopy, the biopsy tissue was tested for lung cancer pathology. A positive diagnosis was defined when the pathology report was a neoplastic lesion (benign or malignant tumor). A positive diagnosis was also made if the pathology report was a granulomatous lesion (with tuberculosis or fungus). If the pathology was reported as an inflammatory cell infiltration or other non-specific inflammation in the lungs, the subject underwent another pathology biopsy after at least 3 months of follow-up to rule out false-positive results due to a change in the site of the lesion.

Secondary outcomes

  1. Adverse events

    Time frame: 3 days after navigational tracheoscopic biopsy

    Patients underwent a follow-up period of 3 days after navigational tracheoscopic biopsy, and subjects were followed for adverse events such as hemoptysis, pneumothorax, and mediastinal emphysema.

Sponsors and collaborators

Lead sponsor

Jisong Zhang

Other

Registry information

Official study title

Research on New Intelligent Diagnosis and Treatment Technologies for Early Lung Cancer Based on Multimodal Imaging Bronchoscopy Navigation

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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