The Canada Lymph Node Score: A Feasibility Randomized Controlled Trial (CLNS)
Non Small Cell Lung Cancer
About this trial
This is an interventional diagnostic trial for Non Small Cell Lung Cancer focused on measuring Endobronchial Ultrasound, Diagnostic Imaging, Feasibility, Randomized Controlled Trial, Clinical N0-N1 Disease
Eligibility Criteria
Inclusion Criteria:
- Referred to have EBUS for staging of confirmed or suspected NSCLC
- Completed both a CT and PET scans
- cN0-cN1 disease indicated on CT and PET scans
Exclusion Criteria:
- Patients with cN0 disease, peripheral tumours and tumours < 2 cm in diameter (they do not require staging)
- Evidence of cN2 disease or higher on CT and PET scan
Sites / Locations
- St. Joseph's Healthcare Hamilton
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Systematic Sampling
Selective Targeted Sampling
Patients will undergo systematic sampling of lymph node stations in the mediastinum with a minimum sampling of 3 stations: 4R, 4L and 7, as is the standard of care. Other stations may be included at the endoscopist's discretion. CLNS is not used for this arm.
Patients will first undergo endosonographic assessment of 3 mediastinal lymph node stations (i.e. 4R, 4L, and 7) using the four criteria of the CLNS. Lymph node stations that exhibit a CLNS >1/4 will be biopsied as is standard of care. Lymph node stations with CLNS ≤ 1/4 will be marked as "not requiring biopsy" but will be biopsied nevertheless, so that there is no deviation from the standard of care. Other stations may be included at the endoscopist's discretion.