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NCT Number: NCT07595120

Application of Electromagnetic Navigation System in Pulmonary Nodule Localization

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.

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Key information

Conditions

Pulmonary Nodules Early-Stage Lung Cancer Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Electromagnetic Navigation-Guided Percutaneous Localization of Pulmonary Nodules

Procedure

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.

CT-Guided Percutaneous Localization of Pulmonary Nodules

Procedure

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.

Primary outcomes

  1. Success rate of intraoperative localization of lung nodules

    Time frame: Day 0 (Intraoperative)

    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.

Secondary outcomes

  1. Localization Accuracy

    Time frame: Day 0 (Intraoperative)

    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.

  2. Location Procedure Time

    Time frame: Day 0 (Intraoperative)

    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).

  3. Conversion Rate

    Time frame: Day 0 (Intraoperative)

    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).

  4. Complication Rate

    Time frame: Day 0 through hospital discharge or Day 7 postoperatively, whichever comes first

    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.

  5. Radiation Exposure

    Time frame: Day 0 (Intraoperative)

    Dose-length product (DLP) value of radiation received by the patient, as recorded by the CT scanner (unit: mGy·cm).

  6. Operative Time

    Time frame: Day 0 (Intraoperative)

    Time from the initiation of the skin incision for thoracoscopy to the completion of wound closure (unit: min).

  7. Early Postoperative Pain Score

    Time frame: Day 0 (immediately after localization); 24 hours postoperatively

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Shenghao Huang

CONTACT

[email protected]

+86 153 5656 1656

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

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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