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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


N/A
21 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


Inclusion Criteria:



- Require either surgical or minimally invasive evaluation (EUS/EBUS) of the
mediastinum

- Are medically fit to undergo surgery

- Possess known or suspected non-small cell carcinoma of the lung

- Have had PET/CT scan within 45 days of randomization

- Are eligible for complete mediastinal lymph node dissection at surgery if clinically
indicated (determined at surgery)

Exclusion Criteria:

- Pathologically documented metastatic disease

- History of malignancy within 5 years other than (skin) basal cell carcinoma

- Bulky mediastinal lymphadenopathy defined as lymph node > 2.0 cm in short axis
diameter or contralateral adenopathy or direct invasion mediastinum or great vessels
(T4 disease) or have a malignant pleural effusion.

- Peripheral T1 tumors with radiographically normal mediastinum on PET/CT.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Accuracy of each arm for the staging of lung cancer

Outcome Description:

We will be testing whether or not the sensitivity of the EUS/EBUS technique for identifying malignant mediastinal lymph nodes is more than 10% worse than the sensitivity of the Mediastinoscopy technique. The primary analysis will be a direct comparison of the sensitivities of the 2 measures, where the sensitivity is defined as the number of true positive cases divided by the sum of the true positives and the false negatives, or the proportion of patients who truly have malignant mediastinal lymph nodes that test positive (i.e. via EUS/EBUS or Mediastinoscopy).

Outcome Time Frame:

Two years

Safety Issue:

No

Principal Investigator

Gerard A Silvestri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Institutional Review Board

Study ID:

A-13245.8

NCT ID:

NCT01117714

Start Date:

September 2009

Completion Date:

December 2010

Related Keywords:

  • Lung Cancer
  • Lung cancer
  • Lung neoplasm
  • Pulmonary cancer
  • Pulmonary neoplasm
  • Lung cancer staging
  • Lung Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Mayo ClinicJacksonville, Florida  32224