Real-Time Non-Invasive Localization for Multiple Lung Nodules

Guangzhou Medical University

Status: Completed

Conditions: Lung Cancer (NSCLC)

Treatments: Procedure: Real-time non-invasive localization; Procedure: Manual needle localization

Study type: Interventional

Funder types: Other

Identifiers

NCT07257549

Non-invasive localization

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Non-invasive group

Experimental group

Description:

Real-time non-invasive localization of multiple pulmonary nodules

Treatment:

Procedure: Real-time non-invasive localization

CT-guided group

Active Comparator group

Description:

Manual CT-guided percutaneous needle localization of multiple pulmonary nodules

Treatment:

Procedure: Manual needle localization