Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)
The goal of this clinical research study is to learn how accurately an endobronchial ultrasound transbronchial needle aspiration (EBUS -TBNA) may detect mediastinal lymph node metastases in patients with clinical stage I and II non-small cell lung cancer (NSCLC).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Diagnostic Utility of Endobronchial Ultrasound Guided Mediastinal Lymph Node Sampling in Clinical Stage I and II Non Small Cell Lung Cancer|
- Number of Participants with False Negative Rate Using EBUS Guided Mediastinal Lymph Node Biopsy [ Time Frame: Patient participation 1 hour to complete EBUS-TBNA ] [ Designated as safety issue: No ]False negative rate estimated using EBUS guided mediastinal lymph node biopsy following a negative PET scan with a 90% credible interval.
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||April 2017 (Final data collection date for primary outcome measure)|
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA)
Tissue sample collected bronchoscope using needle aspirate of lung lymph gland, procedure takes 1 hour.
Other Name: Endobronchial Ultrasound Transbronchial Needle Aspiration
A procedure called EBUS-TBNA has been developed that might allow doctors to get samples of lymph glands without performing an operation. The standard practice is a surgical operation called a mediastinoscopy. If researchers find out that EBUS-TBNA is as accurate as mediastinoscopy, it may mean that patients with lung cancer can avoid having surgery or will be able to get treatment before surgery.
If you agree to take part in this study, you will first have an EBUS-TBNA. This will be performed on an out-patient basis under general anesthetic. The doctor will examine your lungs for suspicious lymph glands with an ultrasound, and then will take a sample of tissue from the lymph gland. This will be done using a flexible scope called a bronchoscope that can be passed into the windpipe. The lymph glands around the wind pipe can be seen and then removed with a small needle. The procedure should take about 1 hour.
Researchers will then analyze the lymph glands that were removed. Depending on whether or not the lymph glands have cancer in them, your doctor will then recommend the most appropriate therapy for you. This may include mediastinoscopy or some other appropriate therapy.
All the data for the study will be stored with a password protected system.
Length of Study:
Your participation in this study will be over after you have completed EBUS-TBNA.
This is an investigational study. EBUS-TBNA is FDA approved for this procedure.
Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832715
|Contact: George A. Eapen A. Eapen, MD||713-792-4017|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: George A Eapen, MD|
|Principal Investigator:||George A. Eapen, M.D.||M.D. Anderson Cancer Center|