Real-Time Non-Invasive Localization for Multiple Lung Nodules

NCT ID: NCT07257549

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-07-01

Brief Summary

This study compares real-time non-invasive localization and manual CT-guided needle localization for multiple lung nodules under 20 mm. It primarily aims to evaluate the successful resection rate of pulmonary nodules.

Detailed Description

This is a prospective, single-center, non-inferiority clinical study designed to evaluate the effectiveness of a real-time non-invasive localization. The study will be conducted between July 2024 and July 2025, involving 40 patients with multiple lung nodules smaller than 20 mm in diameter. Participants will be randomly assigned to receive either CT-guided manual needle localization or real-time non-invasive localization. The primary outcome measure will be the successful resection rate of pulmonary nodules. Secondary outcome measures will include resection margins, changes in operative approach, intraoperative blood loss, operative time, postoperative hospitalization days, the placement of chest tubes, the duration of chest tube placement, and postoperative complications.

Conditions

Lung Cancer (NSCLC)

Study Design

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

Study Groups

Non-invasive group

Real-time non-invasive localization of multiple pulmonary nodules

Group Type: EXPERIMENTAL

Real-time non-invasive localization

Intervention Type: PROCEDURE

The patient underwent a CT scan prior to surgery. The acquired CT image data was saved in DICOM format and subsequently imported into software for three-dimensional reconstruction of the lung lobes, blood vessels, and bronchi. During the procedure, an assistant created a three-dimensional lung model on a separate monitor, aligning it roughly with the orientation of the deflated lung observed via thoracoscopy. The thoracic surgeon then completed resection of the pulmonary nodule guided by the surgeon's three-dimensional lung model.

CT-guided group

Manual CT-guided percutaneous needle localization of multiple 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. 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. After confirming the needle tip's proximity to the target nodule, indocyanine green (ICG) was injected during deep inspiration to mark the nodule for intraoperative fluorescence imaging. The thoracic surgeon completed resection of the pulmonary nodule based on the area delineated by ICG.

Interventions

Manual needle localization

Manual needle localization involves the traditional technique of percutaneous localization of pulmonary nodules under CT guidance. 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. After confirming the needle tip's proximity to the target nodule, indocyanine green (ICG) was injected during deep inspiration to mark the nodule for intraoperative fluorescence imaging. The thoracic surgeon completed resection of the pulmonary nodule based on the area delineated by ICG.

Intervention Type: PROCEDURE

Real-time non-invasive localization

The patient underwent a CT scan prior to surgery. The acquired CT image data was saved in DICOM format and subsequently imported into software for three-dimensional reconstruction of the lung lobes, blood vessels, and bronchi. During the procedure, an assistant created a three-dimensional lung model on a separate monitor, aligning it roughly with the orientation of the deflated lung observed via thoracoscopy. The thoracic surgeon then completed resection of the pulmonary nodule guided by the surgeon's three-dimensional lung model.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. the maximum diameter of the lesion on CT did not exceed 20 mm;

2. at least two pulmonary nodules identified;

3. pulmonary nodules showed pure ground-glass opacity (GGO) or mixed GGO on imaging;

4. the outer edge of nodules located between 5-20 mm from the nearest pleural surface.

Exclusion Criteria

1. nodule location obstructed by the scapula, precluding needle access;

2. proximity of the nodule to major blood vessels, defined as within 2 cm;

3. 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

Non-invasive localization

Identifier Type: -

Identifier Source: org_study_id