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Completed

NCT Number: NCT07257549

Real-Time Non-Invasive Localization for Multiple Lung Nodules

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.

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Key information

Conditions

Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms 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 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The successful resection rate of pulmonary nodules

    Time frame: Day of surgery.

    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.

Secondary outcomes

  1. Resection margins

    Time frame: Day of surgery.

    Distance from the nodule to the resection margin

  2. Changes in operative approach

    Time frame: Day of surgery.

    During surgery, the planned approach must be changed when the target nodule cannot be completely resected due to various reasons.

  3. Intraoperative blood loss

    Time frame: Day of surgery.

    Hemorrhage during surgery.

  4. Operative time

    Time frame: Day of surgery.

    Total duration of the thoracic surgical procedure, measured in minutes from skin incision to completion of skin closure for the index operation.

  5. Postoperative hospitalization days

    Time frame: Perioperative.

    The postoperative hospitalization duration refers to the total number of days the patient remains in the hospital from the completion of surgery until discharge.

  6. The placement of chest tubes

    Time frame: Day of surgery.

    Determine whether a chest tube needs to be placed based on the patient's condition during surgery.

  7. The duration of chest tube placement

    Time frame: Perioperative.

    The chest tube placement duration refers to the number of days from the placement of the chest tube after surgery until its removal.

  8. Postoperative complications

    Time frame: Perioperative.

    Postoperative complications refer to any adverse events or symptoms that occur after surgery.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2025
Registry last updated
Dec 2, 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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