Research on New Diagnosis and Treatment Technologies for Early Lung Cancer

NCT07000721 | Completed

• 1 other identifier: SirRRSH2024-1000
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lung Cancer, Peripheral Pulmonary Nodules

Keywords

Lung cancer; peripheral pulmonary nodules; AI-constructed airway tree navigation system; diagnosis; effectiveness and safety

Outcome Measures

Primary Outcomes (1)

• Diagnostic positive yield

  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.

  One month after the patients were enrolled

Secondary Outcomes (1)

• Adverse events

  3 days after navigational tracheoscopic biopsy

Study Arms (2)

New navigation system group

EXPERIMENTAL

The new AI-constructed airway tree navigation system (SARS-pro) was used for preoperative navigation path planning. The SARS-pro navigation system was independently developed by the research group based on a conventional augmented reality optical navigation system (LungPro; Bronchus Company).

Diagnostic Test: Preoperative navigation path planning using the SARS-pro navigation system

Old navigation system group

ACTIVE COMPARATOR

Preoperative navigation path planning was performed using the old VBN system (LungPro; Bronchus Company).

Diagnostic Test: Preoperative navigation path planning using the VBN navigation system

Interventions

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).

New navigation system group

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).

Old navigation system group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jisong Zhang: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enguo Chen, MD

  Sir Run Run Shaw Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 3, 2025
• Study Start: August 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)