Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)
Patients with radiologically early stage lung cancer who are candidates for SBRT will be
enrolled in this study. Prior to enrollment, patients are required to be evaluated by an
experienced thoracic surgeon, radiation oncologist or medical oncologist to determine
operability. Patients will udergo computed tomography (CT) and positron emission tomography
(PET) prior to EBUS- TBNA. EBUS-TBNA will be performed at the Interventional Thoracic
Surgery Suite (ITSS) located at Toronto General Hospital by a Thoracic Surgeon. The
procedure will be performed under local anesthesia with conscious sedation. Mediastinal as
well as hilar lymph nodes will be assessed by EBUS-TBNA. The result of pathological
diagnosis using EBUS-TBNA will be compared with the result of radiological staging (CT and
PET-CT). Patients who are negative for mediastinal lymph node metastasis by EBUS-TBNA will
undergo SBRT. In addition, the treatment outcome will be evaluated based on the clinical
chart review.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT).
Primary objective: To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT). In comparing EBUS-TBNA vs. CT/PET the primary outcome measures will be: 1) Sensitivity, 2) Specificity, 3) Positive predictive value, 4) Negative predictive value, 5) Accuracy in detecting malignancy
3 years
No
Kazuhiro Yasufuku, MD
Principal Investigator
UHN
Canada: UHN Research Ethics Board
12-5294-CE
NCT01786590
February 2013
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