search
Back to results

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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EBUS-TBNA
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EBUS-TBNA

Arm Description

Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA)

Outcomes

Primary Outcome Measures

Number of Participants with False Negative Rate Using EBUS Guided Mediastinal Lymph Node Biopsy
False negative rate estimated using EBUS guided mediastinal lymph node biopsy following a negative positron emission tomography (PET) scan with a 90% credible interval.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2009
Last Updated
July 18, 2016
Sponsor
M.D. Anderson Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00832715
Brief Title
Utility of Endobronchial Ultrasound Guided Needle Biopsy in Early Stage Non- Small Cell Lung Cancer (NSCLC)
Official Title
Diagnostic Utility of Endobronchial Ultrasound Guided Mediastinal Lymph Node Sampling in Clinical Stage I and II Non Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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 120 patients will take part in this study. All will be enrolled at MD Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBUS-TBNA
Arm Type
Experimental
Arm Description
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA)
Intervention Type
Procedure
Intervention Name(s)
EBUS-TBNA
Other Intervention Name(s)
Endobronchial Ultrasound Transbronchial Needle Aspiration
Intervention Description
Tissue sample collected bronchoscope using needle aspirate of lung lymph gland, procedure takes 1 hour.
Primary Outcome Measure Information:
Title
Number of Participants with False Negative Rate Using EBUS Guided Mediastinal Lymph Node Biopsy
Description
False negative rate estimated using EBUS guided mediastinal lymph node biopsy following a negative positron emission tomography (PET) scan with a 90% credible interval.
Time Frame
Patient participation 1 hour to complete EBUS-TBNA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must be >/= 18 years old. Patient must have Eastern Cooperative Oncology Group (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George A. Eapen, M.D.
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs