NCT00966511

Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Deep Breeze · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-10-01
• Completion: 2011-12-01
• First posted: 2009-08-27
• Last updated: 2011-02-09

Locations

6 sites across 1 country: United States