Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection
The primary purpose of the study is to investigate the use of VRI to guide the selection of patients for lung surgery. Perfusion scintigraphy is the current method to assess the fractional contribution of lung function of the remaining lung.
The hypothesis is that VRI can determine quantitative postoperative lung function equally accurately as a quantitative perfusion scan.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection|
- Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan [ Time Frame: Prior to surgery ] [ Designated as safety issue: No ]
- Comparison of ppo as predicted by each test with the actual FEV1 and DLCO at 3 months post-operative [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Lung resection candidates
Study participants will be patients who are candidates for lung resection (lobectomy or greater)
Procedure: Lung resection surgery
The study is designed in a way that will not alter the surgeon's decision based on routine assessment of candidates for resection (lobectomy or greater). Namely, the VRI data will be gathered prospectively; however, the analyses using VRI data will be performed retrospectively.
Primarily, VRI will be compared to perfusion (Q) scan by predicted post-operative (ppo) FEV1 and DLCO as predicted by VRI versus as predicted by Q scan. Secondary, the ppo as predicted by each test will be compared with the actual FEV1 and DLCO at 3 months post-operative; If these two methods provide similar results, VRI will be deemed an acceptable alternative to Q scan for determining patient selection for lung resection. Finally, the patient outcomes (30 day mortality and pulmonary complications) for those patients falling within guideline parameters using the VRI measurement will be analyzed to see if using VRI in clinical practice would indeed allow prediction of satisfactory results (similar to literature benchmarks).
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520-8062|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Boston Medical Center, Boston University|
|Boston, Massachusetts, United States, 02118|
|United States, New York|
|Mt. Sinai School of Medicine|
|New York, New York, United States, 10029|
|New York-Presbyterian Hospital/Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Frank C Detterbeck, MD||Yale University Medical School|