Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Lung, Cancer, Ultrasound, Staging
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Intraoperative ultrasound
Type: Device
Overall Status
Not yet recruiting
Summary
All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph node dissection. After completion of the standard of care, intraoperative ultrasound will be used to evaluate lymph node stations for the presence of any missed lymph nodes with particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is hyphothosized that Intra-operative thoracoscopic ultrasound following standard video-assisted thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes in non-small cell lung cancer patients undergoing definitive surgical resection.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

Age ≥18 years. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A). Life expectancy of greater than 3 months

Patients be able to undergo VATS resection as defined below:

- Preoperative FEV1 ≥ 40% predicted

- OR

- Post-operative predicted FEV1 ≥ 0.8 l

- Hg ≥ 8.0

- No evidence of coronary ischemia on stress evaluation Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients with surgery for a prior ipsilateral lung cancer

Patients with known brain metastases

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. (Patients with HIV are not excluded from this study)
Location
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Status: Not yet recruiting
Start Date
June 2015
Completion Date
May 2018
Sponsors
Jeremiah Martin
Source
University of Kentucky
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page