- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00966511
Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection
February 8, 2011 updated by: Deep Breeze
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 Overview
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).
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06520-8062
- Yale University School Of Medicine
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center, Boston University
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New York
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New York, New York, United States, 10029
- Mt. Sinai School of Medicine
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New York, New York, United States, 10032
- New York-Presbyterian Hospital/Columbia University Medical Center
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Md Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Study participants will be patients who are candidates for lung resection (lobectomy or greater)
Description
Inclusion Criteria:
- Able and willing to read, understand, and provide written Informed Consent;
- Age range of 18-90 years;
- Potential candidate for at least lobectomy due to lung cancer or other intrathoracic malignancy (either suspected or proven by biopsy). Both open and minimally invasive (thoracoscopic) resections are acceptable.
- BMI > 19.
Exclusion Criteria:
- Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture);
- There should be no active pulmonary infection (e.g. pneumonia) at the time of the recordings;
- Hirsutism unless patient is willing to have back shaved;
- Potentially contagious skin lesion on the back;
- Giant bulla (more than 1/3 of the hemithorax or >10cm)
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lung resection candidates
Study participants will be patients who are candidates for lung resection (lobectomy or greater)
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan
Time Frame: Prior to surgery
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Prior to surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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3 months after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frank C Detterbeck, MD, Yale University Medical School
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. doi: 10.1159/000103558. Epub 2007 Jun 4.
- Kramer MR, Raviv Y, Hardoff R, Shteinmatz A, Amital A, Shitrit D. Regional breath sound distribution analysis in single-lung transplant recipients. J Heart Lung Transplant. 2007 Nov;26(11):1149-54. doi: 10.1016/j.healun.2007.07.039.
- Guntupalli KK, Reddy RM, Loutfi RH, Alapat PM, Bandi VD, Hanania NA. Evaluation of obstructive lung disease with vibration response imaging. J Asthma. 2008 Dec;45(10):923-30. doi: 10.1080/02770900802395496.
- Yigla M, Gat M, Meyer JJ, Friedman PJ, Maher TM, Madison JM. Vibration response imaging technology in healthy subjects. AJR Am J Roentgenol. 2008 Sep;191(3):845-52. doi: 10.2214/AJR.07.3151.
- Becker HD, Slawik M, Miyazawa T, Gat M. Vibration response imaging as a new tool for interventional-bronchoscopy outcome assessment: a prospective pilot study. Respiration. 2009;77(2):179-94. doi: 10.1159/000182972. Epub 2008 Dec 9.
- Colice GL, Shafazand S, Griffin JP, Keenan R, Bolliger CT; American College of Chest Physicians. Physiologic evaluation of the patient with lung cancer being considered for resectional surgery: ACCP evidenced-based clinical practice guidelines (2nd edition). Chest. 2007 Sep;132(3 Suppl):161S-77S. doi: 10.1378/chest.07-1359.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
August 26, 2009
First Submitted That Met QC Criteria
August 26, 2009
First Posted (Estimate)
August 27, 2009
Study Record Updates
Last Update Posted (Estimate)
February 9, 2011
Last Update Submitted That Met QC Criteria
February 8, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DB041
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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