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

NCT07055997 | Completed

• 1 other identifier: ES-2024-129-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Robotic-assisted; lung nodule; preoperative localization; video-assisted thoracoscopic surgery (VATS); non-inferiority study

Outcome Measures

Primary Outcomes (1)

• Localization Success Rate

  The accuracy of nodule localization was designated as the primary outcome of the study. Successful localization was defined as a distance of less than 10 mm between the needle tip and the center of the nodule, with no displacement of the localization device between localization and surgery.

  Immediately after needle localization and before surgery

Secondary Outcomes (5)

• Procedure Duration

  From patient positioning on the CT scanner to confirmation of successful needle insertion via final CT scan

• Number of CT Scans Required for Localization

  During the localization procedure

• Total Dose-Length Product (DLP)

  During the localization procedure

• First-pass Success Rate

  Immediately after the first needle insertion

• Localization Success Rate within One Needle Adjustment

  Immediately after one needle adjustment

Study Arms (2)

Freehand group

ACTIVE COMPARATOR

Manual CT-guided percutaneous needle localization of pulmonary nodules

Procedure: Manual needle localization

Robotic group

EXPERIMENTAL

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

Device: Robotic-assisted needle localization

Interventions

Robotic-assisted needle localization 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.

Robotic group

Manual needle localization 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.

Freehand group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated of Guangzhou Medical University

Guangzhou, Guangdong, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 9, 2025
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-06

Locations

CN (1)