Real-Time Non-Invasive Localization for Multiple Lung Nodules

Effectiveness of Real-time Non-invasive Localization for Multiple Lung Nodules: a Pilot, Prospective, Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer (NSCLC)
• Intervention / Treatment: Procedure: Real-time non-invasive localization; Procedure: Manual needle localization

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-invasive group; Real-time non-invasive localization of multiple pulmonary nodules	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.
Active Comparator: CT-guided group; Manual CT-guided percutaneous needle localization of multiple pulmonary nodules	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The successful resection rate of pulmonary nodules	The proportion of target lung nodules that are successfully localized and completely resected during the operation, with the target lesion identified in the resected specimen and negative surgical margins confirmed on final pathology.	Day of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resection margins	Distance from the nodule to the resection margin	Day of surgery.
Changes in operative approach	During surgery, the planned approach must be changed when the target nodule cannot be completely resected due to various reasons.	Day of surgery.
Intraoperative blood loss	Hemorrhage during surgery.	Day of surgery.
Operative time	Total duration of the thoracic surgical procedure, measured in minutes from skin incision to completion of skin closure for the index operation.	Day of surgery.
Postoperative hospitalization days	The postoperative hospitalization duration refers to the total number of days the patient remains in the hospital from the completion of surgery until discharge.	Perioperative.
The placement of chest tubes	Determine whether a chest tube needs to be placed based on the patient's condition during surgery.	Day of surgery.
The duration of chest tube placement	The chest tube placement duration refers to the number of days from the placement of the chest tube after surgery until its removal.	Perioperative.
Postoperative complications	Postoperative complications refer to any adverse events or symptoms that occur after surgery.	Perioperative.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: lung cancer; Video-assisted thoracic surgery; lung nodule; Preoperative localization
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Non-invasive localization

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No