An observational study in Lung Cancer, sponsored by Deep Breeze. Status unknown at 6 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-02-09.
Sponsored by Deep Breeze · Observational
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.
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).
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 200 is close to the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Deep Breeze is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study participants will be patients who are candidates for lung resection (lobectomy or greater)
Exclusion Criteria:
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.
Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan
Time frame: Prior to surgery
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
This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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