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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

RecruitingNAAges 18 Years - anyAllMcMaster University
NCT06540196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Lung cancer is the leading cause of annual cancer deaths globally, more than breast, prostate, and colon cancers combined. The staging of chest lymph nodes (LNs) is a crucial step in the lung cancer diagnostic pathway because it aids in treatment decisions - whether a patient is a candidate for lung resection, chemotherapy, radiation, or multimodal treatments. Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) is the current standard for chest nodal staging for non-small cell lung cancer (NSCLC), and guidelines mandate that Systematic Sampling (SS) of at least 3 chest LN stations be routinely performed for accurate staging. Unfortunately, EBUS-TBNA yields inaccurate results in 40% of patients, leading to misinformed treatment decisions. This proportion is much higher in patients with Triple Normal LNs \[LNs that appear normal on computed tomography (CT) scans, positron

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📋 Eligibility rules (as published)
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)
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What it tests

  • NodeAI
  • Surgeon
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Where

1 site
St. Joseph's Healthcare Hamilton
Hamilton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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