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

NCT00970645 | Terminated

• 2 other identifiers: 09-002240DOD protocol A-12345.8
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non small cell lung cancer; mediastinum; endobronchial ultrasound fine needle aspiration; endoscopic ultrasound; mediastinoscopy; surgical or minimally invasive evaluation of mediastinum; NSCLC

Outcome Measures

Primary Outcomes (1)

• Develop an integrated staging technique to detect early metastases in lung cancer which should affect patient outcomes more accurately than conventional staging techniques.

  Post operative

Study Arms (2)

traditional mediastinoscopy/thoracoscopy

ACTIVE COMPARATOR

Traditional Mediastinoscopy used to detect or stage lung cancers.

Procedure: Mediastinoscopy/thoracoscopy

EBUS/EUS

ACTIVE COMPARATOR

Minimal invasive technique for staging/detecting lung cancer.

Procedure: EBUS/EUS

Interventions

Mediastinoscopy/thoracoscopy PROCEDURE

Mediastinoscopy used to detect/stage lung cancer.

Also known as: Lung biopsy

traditional mediastinoscopy/thoracoscopy

EBUS/EUS PROCEDURE

Minimal invasive technique to stage/detect lung cancer.

Also known as: Endobronchial Ultrasound, Endoscopic Ultrasound

EBUS/EUS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Medical University of South Carolina: collaborator

Study Sites (3)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-6300, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Mediastinoscopy; Thoracoscopy; Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Investigative Techniques

Study Officials

• Brenda Hoffman, M.D.

  Medical University of South Carolina

  STUDY CHAIR

• Eric S Edell, M.D.

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

• Michael Wallace, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 18, 2011

Record last verified: 2011-07

Locations

US (3)