Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Procedure: EBUS-TBNA |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| 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 patients 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EBUS-TBNA
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA)
|
Procedure: EBUS-TBNA
Tissue sample collected bronchoscope using needle aspirate of lung lymph gland, procedure takes 1 hour.
Other Name: Endobronchial Ultrasound Transbronchial Needle Aspiration
|
Detailed Description:
Study Procedures:
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.
EBUS-TBNA:
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 100 patients will take part in this study. All will be enrolled at MD Anderson.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must be >/= 18 years old.
- Patient must have ECOG/Zubrod status 0-2.
- Patient must have proven or suspected NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I or II, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer (T1-3 N0, T1-2 N1).
- Patient must be eligible for definitive surgical therapy for primary NSCLC.
- Patient or the patient's legally acceptable representative must provide written informed consent prior to registration and any study-related procedures.
- If the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a. Patient has undergone potentially curative therapy for all prior malignancies. b. No evidence of active / recurrent disease.
- All females of childbearing age must have a negative pregnancy test before beginning the study.
Exclusion Criteria:
- Patient has received prior chemotherapy or radiotherapy for this cancer.
- Patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
- Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy.
- Patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology.
- Patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate).
- Females who are pregnant and/or lactating.
Contacts and Locations| Contact: George A. Eapen A. Eapen, MD | 713-792-4017 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: George A Eapen, MD | |
| Principal Investigator: | George A. Eapen, M.D. | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00832715 History of Changes |
| Other Study ID Numbers: | 2007-0387 |
| Study First Received: | January 29, 2009 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Lung Lung Cancer NSCLC Non Small Cell Lung Cancer Squamous Cell Adenocarcinoma Large Cell Endobronchial Ultrasound Transbronchial Needle Aspiration Mediastinal lymph node negative disease Mediastinal Nodal Metastasis EBUS-FNA |
Endobronchial Ultrasound Fine Needle Aspiration EBUS guided needle mediastinal lymph node biopsy Biopsy PET scan Positron Emission Tomography CT Scans Computed Tomography Scans Lymph node Mediastinoscopy Bronchoscope |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013