Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832715
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : July 20, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Procedure: EBUS-TBNA Phase 1 Phase 2

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.


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2009
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of Participants with False Negative Rate Using EBUS Guided Mediastinal Lymph Node Biopsy [ Time Frame: Patient participation 1 hour to complete EBUS-TBNA ]
    False negative rate estimated using EBUS guided mediastinal lymph node biopsy following a negative positron emission tomography (PET) scan with a 90% credible interval.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient must be >/= 18 years old.
  2. Patient must have Eastern Cooperative Oncology Group (ECOG)/Zubrod status 0-2.
  3. 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).
  4. Patient must be eligible for definitive surgical therapy for primary NSCLC.
  5. Patient or the patient's legally acceptable representative must provide written informed consent prior to registration and any study-related procedures.
  6. 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.
  7. All females of childbearing age must have a negative pregnancy test before beginning the study.

Exclusion Criteria:

  1. Patient has received prior chemotherapy or radiotherapy for this cancer.
  2. Patient is considered a poor risk for surgery due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
  3. Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy.
  4. Patients malignancy consistent with well differentiated (carcinoid) neuroendocrine histology.
  5. Patient has two separate same histology lung tumors (where the question of two separate primaries or metastatic disease makes definitive clinical staging inaccurate).
  6. Females who are pregnant and/or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00832715

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: George A. Eapen, M.D. M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00832715     History of Changes
Other Study ID Numbers: 2007-0387
NCI-2015-01900 ( Registry Identifier: NCI CTRP )
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Non Small Cell Lung Cancer
Squamous Cell
Large Cell
Endobronchial Ultrasound Transbronchial Needle Aspiration
Mediastinal lymph node negative disease
Mediastinal Nodal Metastasis
Endobronchial Ultrasound Fine Needle Aspiration
EBUS guided needle mediastinal lymph node biopsy
PET scan
Positron Emission Tomography
CT Scans
Computed Tomography Scans
Lymph node

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms