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Completed

NCT Number: NCT07055997

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

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.

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Key information

Conditions

Lung Nodules Disease Lung Cancer (Diagnosis) Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Robotic-Assisted Navigation System Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated of Guangzhou Medical University

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Localization Success Rate

    Time frame: Immediately after needle localization and before surgery

    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.

Secondary outcomes

  1. Procedure Duration

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

    Procedure duration was calculated from the time the patient was positioned on the CT scanner to the confirmation of successful needle insertion via the final CT scan.

  2. Number of CT Scans Required for Localization

    Time frame: During the localization procedure

    The number of CT scans needed to successfully localize the nodule.

  3. Total Dose-Length Product (DLP)

    Time frame: During the localization procedure

    The total dose-length product (DLP) accumulated during the localization process.

  4. First-pass Success Rate

    Time frame: Immediately after the first needle insertion

    First-pass success was defined as the successful localization of the nodule with the first needle insertion, without requiring any needle adjustment.

  5. Localization Success Rate within One Needle Adjustment

    Time frame: Immediately after one needle adjustment

    The localization success rate within one needle adjustment was defined as successful localization achieved after a single adjustment to the needle's depth or angle following initial misplacement.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

The Effectiveness of Robotic-assisted Navigation System for Preoperative Lung Nodule Localization: a Prospective, Single-center, Non-inferiority Clinical Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 9, 2025
Registry last updated
Jul 9, 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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