Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection
| Tracking Information | |||||
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| First Received Date ICMJE | August 26, 2009 | ||||
| Last Updated Date | February 8, 2011 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00966511 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection | ||||
| Official Title ICMJE | Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection | ||||
| Brief 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. |
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| 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). |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Study participants will be patients who are candidates for lung resection (lobectomy or greater) |
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| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | Lung resection candidates
Study participants will be patients who are candidates for lung resection (lobectomy or greater)
Intervention: Procedure: Lung resection surgery |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00966511 | ||||
| Other Study ID Numbers ICMJE | DB041 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Merav Gat / VP Clinical Affairs, Deep Breeze | ||||
| Study Sponsor ICMJE | Deep Breeze | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Deep Breeze | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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