Application of Electromagnetic Navigation System in Pulmonary Nodule Localization

Electromagnetic Navigation-Guided Versus CT-Guided Localization of Pulmonary Nodules: A Multicenter, Prospective, Randomized Controlled Trial

This study aims to design and conduct a multicenter, prospective, randomized controlled post-market clinical trial to validate the clinical efficacy of high-precision electromagnetic navigation technology.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Nodules; Early-Stage Lung Cancer
• Intervention / Treatment: Procedure: Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules; Procedure: CT-Guided Percutaneous Localization of Pulmonary Nodules

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shenghao Huang; Phone Number: +86 153 5656 1656; Email: huangshplus5@163.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Pulmonary Hospital
    • Contact: Haifeng Wang; Phone Number: +8602156561656; Email: huangshplus5@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age 18-80 years, regardless of gender;
2. Solitary single nodule, scheduled for lung nodule puncture and localization;
3. Chest CT (lung window mode) showing a maximum nodule diameter ≤ 2 cm;
4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-2;
5. Voluntary participation, with signed informed consent.

Exclusion Criteria:

1. Not suitable for video-assisted thoracoscopic surgery;
2. The distance between the center of the lesion and the dome of the diaphragm is < 3 cm;
3. History of thoracic adhesion due to previous thoracotomy or pleural infection;
4. Patients judged by the investigator to be unsuitable for preoperative transthoracic or transbronchial localization;
5. Inability to complete follow-up or poor compliance.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electromagnetic Navigation Localization Group	Procedure: Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules; Performed by an experienced thoracic surgeon or interventional radiologist under general or local anesthesia, the procedure is guided by an electromagnetic navigation system. The procedural steps include: 1) preoperative import of the patient's CT data into the navigation system for path planning; 2) intraoperative coupling of the positioning sensor with the puncture instrument; 3) under real-time three-dimensional imaging guidance of the electromagnetic navigation system, performing percutaneous puncture to accurately place a positioning guidewire / microcoil / dye near the target pulmonary nodule; 4) postoperative CT scan to confirm the localization. This is a single-session procedure.
Active Comparator: CT-Guided Localization Group	Procedure: CT-Guided Percutaneous Localization of Pulmonary Nodules; Performed by an experienced thoracic surgeon or interventional radiologist under local anesthesia, the procedure is guided using a CT scanner. The steps include: 1) positioning the patient appropriately and performing a CT scan to determine the puncture site and path; 2) employing CT fluoroscopy or intermittent CT scanning for real-time guidance; 3) under CT image guidance, performing a percutaneous puncture to place a localization guidewire / microcoil / dye near the target pulmonary nodule; 4) performing a repeat CT scan post-procedure to confirm the localization position. This is a single-session procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of intraoperative localization of lung nodules	Thoracoscopic exploration enables accurate identification and localization of markers (e.g., contrast dye, microcoils, etc.), with the distance between the center of the marker or the main imaging area and the center of the target nodule being ≤20 mm, and ultimately successfully guides the resection of the target lesion.	Day 0 (Intraoperative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localization Accuracy	The shortest physical distance (unit: mm) between the actual localization marker point (e.g., the center of the dye) and the outer edge of the nodular lesion in the resected specimen.	Day 0 (Intraoperative)
Location Procedure Time	CT-guided group: Time from the start of the initial localization planning CT scan to the completion of marker/needle deployment and withdrawal of instruments from the body surface. Electromagnetic navigation group: Time from when the bronchoscope passes the vocal cords to the completion of marker deployment and withdrawal of the guiding instrument (unit: min).	Day 0 (Intraoperative)
Conversion Rate	The proportion of subjects in whom conversion from complete thoracoscopy to thoracotomy, or from the planned sublobar resection (wedge/segment) to an extended resection (e.g., lobectomy), was necessitated due to failure to locate the lesion, insufficient surgical margin resulting from excessive localization error, or severe complications related to localization (such as major hemorrhage).	Day 0 (Intraoperative)
Complication Rate	Record the incidence of all complications related to the localization procedure. In addition to complications common to percutaneous approaches, such as pneumothorax and intrathoracic hemorrhage, airway-related complications, including airway mucosal injury/bleeding, bronchospasm, and severe hypoxemia, should be systematically documented. Assessment should be performed based on the adverse event grading criteria.	Day 0 through hospital discharge or Day 7 postoperatively, whichever comes first
Radiation Exposure	Dose-length product (DLP) value of radiation received by the patient, as recorded by the CT scanner (unit: mGy·cm).	Day 0 (Intraoperative)
Operative Time	Time from the initiation of the skin incision for thoracoscopy to the completion of wound closure (unit: min).	Day 0 (Intraoperative)
Early Postoperative Pain Score	Visual Analog Scale (VAS) or Numeric Rating Scale (NRS), scored from 0 to 10 points (with 0 representing no pain and 10 representing the most severe pain).	Day 0 (immediately after localization); 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Principal Investigator: Haifeng Wang, Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 16, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: localization; pulmonary nodules; ENB; CT-guided Percutaneous
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules
• Other Study ID Numbers: IRB-K26-427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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