The Canada Lymph Node Score Project: A Crossover Trial (CLNS)
Lung Cancer, Non Small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring Mediastinal Staging, Nodal Disease, Endobronchial Ultrasound, Diagnostic Testing
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Both CT and PET scans completed prior to EBUS
- Suspected or confirmed NSCLC requiring mediastinal staging
- cN0-cN1 as indicated by CT and PET scans
Exclusion Criteria:
- Patients with cN0 disease AND peripheral tumors AND tumor < 2 cm in diameter, as they do not require mediastinal staging
- Evidence of cN2 disease or higher on CT and PET scans
Sites / Locations
- Royal Alexandra Hospital
- Health Sciences Centre
- St. Joseph's Healthcare Hamilton
- McMaster University
- Toronto General Hospital
- CHUM Endoscopic Tracheo-bronchial and Oesophageal Center
- MUHC Interventional Pulmonology Department
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Selective Targeted Sampling
Systematic Sampling
During patients' Endobronchial Ultrasound (EBUS) procedure, they will first undergo: Selective Targeted Sampling - endosonographic assessment of at least 3 mediastinal lymph node stations (4R, 4L, and 7) using the four criteria of the Canada Lymph Node Score (predictor of nodal disease during Endobronchial Ultrasound). Each lymph node will be assigned a CLNS ranging from 0 to 4. Triple Normal lymph nodes will be defined as those that appear normal on CT (diameter < 1 cm), AND normal on PET (SUV < 2.5), AND normal on EBUS (CLNS < 2). Lymph nodes that are found to be Triple Normal will be marked as "Not for Biopsy", whereas all other lymph nodes will be biopsied.
Upon completion of Systematic Targeted Sampling, all patients will crossover and receive the standard of care: Systematic Sampling - all lymph nodes previously marked as "Not for Biopsy" will be biopsied. At the conclusion of the EBUS procedure, all nodal stations would have been sampled as is mandated by current guidelines.