Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer

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: NCT00970645
Recruitment Status : Terminated (Similar study published results)
First Posted : September 2, 2009
Last Update Posted : July 18, 2011
Medical University of South Carolina
Information provided by:
Mayo Clinic

Brief Summary:
This is a prospective randomized clinical trial with the study cohort comprised of all male and female patients over the age of 21 presenting to the study site for evaluation of lung cancer. The study will enroll 300 subjects, with 150 in each arm. Three sites will be in the study, Mayo Rochester, Mayo Jacksonville and Medical University of South Carolina. Mayo Rochester will enroll approximately 125 subjects. This study does not require subjects to undergo any additional procedures than what they would receive per standard medical care. The consenting subjects will receive EUS and /or EBUS- guided FNA or Mediastinoscopy/Thoracoscopy.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Procedure: Mediastinoscopy/thoracoscopy Procedure: EBUS/EUS Not Applicable

Detailed Description:
This is a prospective randomized clinical trial of males and females age 21 or older being evaluated for lung cancer. The study will enroll approximately 300 subjects (150 in each arm) at 3 participating centers (MUSC, Mayo Clinic Rochester and Jacksonville). This sample size will provide sufficient statistical power (i.e. >80%) using a non-inferiority study design with 1-sided hypothesis testing (Farrington and Manning 1990) to determine whether or not the sensitivity of the EUS/EBUS diagnostic technique is inferior (i.e. 10% or more lower) when compared to the sensitivity of malignant mediastinal adenopathy of about 40%. This study requires subjects to agree to the selection of their standard of care procedure. Subjects will be randomized (stratified computer generated randomization stratified y center and y CT positivity for pathologically enlarged [>1cm short axis] node - 10 strata). Randomization will use variable block sizes (4-8), so that randomization allocation remains concealed as investigators will not be blinded. This study requires subjects to consent to the release of outcome data and follow-up data to be used for study analysis. No additional visit will be required for this study; this study will not require any additional time requirements beyond their scheduled evaluations.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Multicenter Study Comparing Endobronchial and Endoscopic Ultrasound-Guided FNA to Mediastinoscopy/Thoracoscopy in the Staging and Early Detection of Metastases in Lung Cancer
Study Start Date : February 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: traditional mediastinoscopy/thoracoscopy
Traditional Mediastinoscopy used to detect or stage lung cancers.
Procedure: Mediastinoscopy/thoracoscopy
Mediastinoscopy used to detect/stage lung cancer.
Other Name: Lung biopsy

Active Comparator: EBUS/EUS
Minimal invasive technique for staging/detecting lung cancer.
Procedure: EBUS/EUS
Minimal invasive technique to stage/detect lung cancer.
Other Names:
  • Endobronchial Ultrasound
  • Endoscopic Ultrasound

Primary Outcome Measures :
  1. Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques. [ Time Frame: Post operative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 21 years or greater
  • Pt is a surgical candidate for mediastinoscopy, thoracoscopy, or lung resection
  • Known or suspected non-small cell carcinoma of the lung eligible for resection
  • CT scan performed within 45 days prior to evaluation for study participation
  • PET scan performed within 45 days prior to evaluation for study participation

Exclusion Criteria:

  • Pathologically proven metastatic disease
  • History of malignancy within 5 years other than (skin) basal cell carcinoma
  • Enlarged ipsilateral mediastinal lymph nodes > 2.5 cm in diameter
  • Peripheral T1 tumors with normal mediastinal lymph nodes on CT and PET

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): NCT00970645

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-6300
Sponsors and Collaborators
Mayo Clinic
Medical University of South Carolina
Study Chair: Brenda Hoffman, M.D. Medical University of South Carolina
Principal Investigator: Eric S Edell, M.D. Mayo Clinic, Rochester, MN
Principal Investigator: Michael Wallace, M.D. Mayo Clinic

Responsible Party: Eric S. Edell, M.D., Mayo Clinic, Rochester Identifier: NCT00970645     History of Changes
Other Study ID Numbers: 09-002240
DOD protocol A-12345.8
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: July 18, 2011
Last Verified: July 2011

Keywords provided by Mayo Clinic:
Non small cell lung cancer
endobronchial ultrasound fine needle aspiration
endoscopic ultrasound
surgical or minimally invasive evaluation of mediastinum

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