Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer
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ClinicalTrials.gov Identifier: NCT00970645 |
Recruitment Status
:
Terminated
(Similar study published results)
First Posted
: September 2, 2009
Last Update Posted
: July 18, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Procedure: Mediastinoscopy/thoracoscopy Procedure: EBUS/EUS | Not Applicable |
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 |

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

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
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

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 ClinicalTrials.gov 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 |
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 |
ClinicalTrials.gov 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 mediastinum endobronchial ultrasound fine needle aspiration endoscopic ultrasound |
mediastinoscopy surgical or minimally invasive evaluation of mediastinum NSCLC |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |