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Research on New Diagnosis and Treatment Technologies for Early Lung Cancer

NCT ID: NCT07000721

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Lung Cancer, Peripheral Pulmonary Nodules

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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New navigation system group

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).

Group Type EXPERIMENTAL

Preoperative navigation path planning using the SARS-pro navigation system

Intervention Type 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).

Old navigation system group

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

Group Type ACTIVE_COMPARATOR

Preoperative navigation path planning using the VBN navigation system

Intervention Type 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).

Interventions

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Preoperative navigation path planning using the SARS-pro navigation system

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).

Intervention Type DIAGNOSTIC_TEST

Preoperative navigation path planning using the VBN navigation system

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.).
2. Those with incomplete clinical data.
3. Those with missing visits after biopsy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jisong Zhang

OTHER

Sponsor Role lead

Responsible Party

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Jisong Zhang

Doctor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Enguo Chen, MD

Role: STUDY_DIRECTOR

Sir Run Run Shaw Hospital

Locations

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Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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SirRRSH2024-1000

Identifier Type: -

Identifier Source: org_study_id

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