Real-Time Non-Invasive Localization for Multiple Lung Nodules

NCT07257549 | Completed

• 1 other identifier: Non-invasive localization
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (NSCLC)

Keywords

Preoperative localization; lung nodule; lung cancer; Video-assisted thoracic surgery

Outcome Measures

Primary Outcomes (1)

• The successful resection of all planned target nodules per patient

  The primary outcome of this study was the successful resection of all planned target nodules per patient. A lesion was considered successfully resected if the surgical margin was equal to or greater than either the lesion diameter or 2 cm. Generally, after intraoperative resection of the lesion, the margin length was verified by direct measurement on the resected deflated lung specimen. If macroscopic measurement of the surgical margin was challenging, the distance from the nodule to the marker was assessed using intraoperative frozen section analysis. Additionally, any change in surgical approach resulting from unsuccessful nodule localization was considered a failure of lesion resection, regardless of margin size.

  Day of surgery.

Secondary Outcomes (8)

• Resection margins

  Day of surgery.

• Changes in operative approach

  Day of surgery.

• Intraoperative blood loss

  Day of surgery.

• Operative time

  Day of surgery.

• Postoperative hospitalization days

  Perioperative.

Study Arms (2)

Non-invasive group

EXPERIMENTAL

Real-time non-invasive localization of multiple pulmonary nodules

Procedure: Real-time non-invasive localization

CT-guided group

ACTIVE COMPARATOR

Manual CT-guided percutaneous needle localization of multiple pulmonary nodules

Procedure: Manual needle localization

Interventions

Manual needle localization 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.

CT-guided group

Real-time non-invasive localization 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.

Non-invasive 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:

• the maximum diameter of the lesion on CT did not exceed 20 mm;
• at least two pulmonary nodules identified;
• pulmonary nodules showed pure ground-glass opacity (GGO) or mixed GGO on imaging;
• the outer edge of nodules located between 5-20 mm from the nearest pleural surface.

You may not qualify if:

• nodule location obstructed by the scapula, precluding needle access;
• proximity of the nodule to major blood vessels, defined as within 2 cm;
• 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; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

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: November 20, 2025
• First Posted: December 2, 2025
• Study Start: July 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

CN (1)