Robotic-Assisted Navigation for Lung Nodule Localization: A Non-Inferiority Study

NCT ID: NCT07055997

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-03-01

Brief Summary

This study compares robotic-assisted navigation and manual CT-guided needle localization for lung nodules under 20 mm. It aims to evaluate localization success, procedure duration, CT scans, and complication rates.

Detailed Description

This is a prospective, single-center, non-inferiority clinical study designed to evaluate the effectiveness of a robotic-assisted navigation system for lung nodule localization compared to traditional manual CT-guided needle localization. The study will be conducted between June 2024 and December 2024, involving 100 patients with lung nodules smaller than 20 mm in diameter. Participants will be randomly assigned to receive either CT-guided manual needle localization or robotic-assisted needle localization. The primary outcome measure will be the localization success rate, defined as the ability to accurately locate the nodule and guide the needle to the target site for biopsy or surgery. Secondary outcome measures will include procedural duration, the number of CT scans required, total dose-length product (DLP), first-pass success rate, localization success within a single needle adjustment, and complication rate.

Conditions

Lung Nodules; Lung Cancer (Diagnosis); Robotic-Assisted Navigation System

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Freehand group

Manual CT-guided percutaneous needle localization of pulmonary nodules

Group Type: ACTIVE_COMPARATOR

Manual needle localization

Intervention Type: PROCEDURE

Manual needle localization involves the traditional technique of percutaneous localization of pulmonary nodules under CT guidance without the assistance of robotic systems. The procedure is performed by the physician manually guiding the needle based on real-time CT imaging. The physician adjusts the needle position based on visual cues from the CT scan, which may require multiple attempts for accurate localization.

Robotic group

Robotic-assisted CT-guided percutaneous needle localization of pulmonary nodules

Group Type: EXPERIMENTAL

Robotic-assisted needle localization

Intervention Type: DEVICE

Robot-assisted needle localization involves the use of a robotic system to assist with the percutaneous localization of pulmonary nodules under CT guidance. The robotic system provides real-time navigation and increased precision during needle placement, reducing the variability in positioning and improving the accuracy of localization. The system offers automatic adjustments to the needle's trajectory, minimizing the need for manual corrections, and potentially reducing the number of CT scans required. This method is designed to enhance the overall localization success rate and reduce complications associated with traditional manual techniques.

Interventions

Robotic-assisted needle localization

Robot-assisted needle localization involves the use of a robotic system to assist with the percutaneous localization of pulmonary nodules under CT guidance. The robotic system provides real-time navigation and increased precision during needle placement, reducing the variability in positioning and improving the accuracy of localization. The system offers automatic adjustments to the needle's trajectory, minimizing the need for manual corrections, and potentially reducing the number of CT scans required. This method is designed to enhance the overall localization success rate and reduce complications associated with traditional manual techniques.

Intervention Type: DEVICE

Manual needle localization

Manual needle localization involves the traditional technique of percutaneous localization of pulmonary nodules under CT guidance without the assistance of robotic systems. The procedure is performed by the physician manually guiding the needle based on real-time CT imaging. The physician adjusts the needle position based on visual cues from the CT scan, which may require multiple attempts for accurate localization.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

(Ⅰ) isolated pulmonary nodules with a maximum diameter of less than 20 mm; (Ⅱ) the presence of pure ground-glass opacity (GGO) or mixed GGO (solid to tumor ratio < 0.5) on CT with clinical or radiological suspicion of malignancy; (Ⅲ) patient with a peripheral nodule, located in the outer third of the lung parenchyma, with its edge situated at least 5 mm away from the pleural surface; (Ⅳ) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1, indicating suitability for surgical intervention.

Exclusion Criteria

(Ⅰ) nodule location obstructed by the scapula, precluding needle access; (Ⅱ) proximity of the nodule to major blood vessels, defined as within 2 cm; (Ⅲ) requirement for localization of multiple pulmonary nodules.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jianxing He

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ES-2024-129-02

Identifier Type: -

Identifier Source: org_study_id