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Search / Trial NCT06540196

The Development, Safety, and Feasibility of an Artificial Intelligence-Powered Platform (NodeAI) for Real-Time Prediction of Mediastinal Lymph Node Malignancy During Endobronchial Ultrasound Staging for Lung Cancer

Launched by ST. JOSEPH'S HEALTHCARE HAMILTON · Aug 1, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called NodeAI, which uses artificial intelligence (AI) to help doctors better predict whether lymph nodes (small glands that can indicate cancer spread) are cancerous during a procedure known as Endobronchial Ultrasound (EBUS) staging for lung cancer. Lung cancer is a serious disease, and accurately determining the stage of the cancer is essential for deciding the best treatment options. Unfortunately, the current method, EBUS, can sometimes give incorrect results, which can lead to delays in treatment and poor decisions regarding care. The goal of this trial is to test a new device that provides real-time results to doctors, which could improve the accuracy of lymph node assessments.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with suspected or confirmed non-small cell lung cancer (a common type of lung cancer) based on imaging tests like CT and PET scans. They should also be scheduled for chest staging using EBUS. However, those with certain types of tumors, particularly small ones or tumors that don't require staging, will not be eligible. Participants in the trial can expect to have their lymph node images analyzed by the new AI tool during their staging procedure, which may help improve their treatment decisions.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients ≥ 18 years of age diagnosed with suspected or confirmed NSCLC based on CT and PET scans that are referred for chest staging by EBUS-TBNA
  • CT and PET scans completed
  • Exclusion Criteria:
  • Patients with cN0 disease AND peripheral tumors AND tumors \< 2 cm in diameter (those do not require chest staging)

About St. Joseph's Healthcare Hamilton

St. Joseph's Healthcare Hamilton is a leading academic health sciences organization dedicated to advancing patient care through innovative research and clinical trials. With a strong commitment to excellence in healthcare delivery, the institution integrates research, education, and community service to enhance the health and well-being of the populations it serves. St. Joseph's Healthcare Hamilton emphasizes collaboration across disciplines and partners with various stakeholders to facilitate groundbreaking studies in diverse medical fields, fostering a culture of discovery and improving treatment outcomes.

Locations

Hamilton, Ontario, Canada

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported