Lung CancerNCT00966511
Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection
An observational study of Lung Cancer, run by Deep Breeze at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Lung resection surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be patients who are candidates for lung resection (lobectomy or greater)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30322
Boston Medical Center, Boston University
Boston, Massachusetts, 02118
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Yale University School of Medicine
New Haven, Connecticut, 06520-8062
Mt. Sinai School of Medicine
New York, New York, 10029
New York-Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032
About this study
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.
Read the 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
- Being tested
- Lung resection surgery
- Keywords
- lung cancer, lung resection, lobectomy, pneumonectomy, lung function, perfusion
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung resection surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Lung resection candidates | Study participants will be patients who are candidates for lung resection (lobectomy or greater) Receives: Procedure: Lung resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan
Measured: Prior to surgery
Secondary outcomes (1)
Comparison of ppo as predicted by each test with the actual FEV1 and DLCO at 3 months post-operative
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deep Breeze
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank C Detterbeck, MD, Principal investigator, Yale University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966511
- Sponsor's protocol ID
- DB041
- Status last verified
- Feb 2011
- First submitted
- 26 Aug 2009
- Last updated
- 9 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17551264Kramer 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.
PubMed 18022081Yigla 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.
PubMed 18716118Guntupalli 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.
PubMed 19085584Becker 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.
PubMed 19065052Colice 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.
PubMed 17873167
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Response Imaging (VRI) in Patients Who Are Potential Candidates for Surgical Resection
- ClinicalTrials.gov ID
- NCT00966511
- Acronym / sponsor ID
- DB041
- Conditions
- Lung Cancer
- Keywords
- lung cancer, lung resection, lobectomy, pneumonectomy, lung function, perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Deep BreezeIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung resection candidates | – | Procedure: Lung resection surgeryStudy participants will be patients who are candidates for lung resection (lobectomy or greater) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be patients who are candidates for lung resection (lobectomy or greater)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung resection surgeryThe 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. | Procedure or surgery | Lung resection candidates |
Primary outcome
Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan
Time frame: Prior to surgery
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2011.
- Background: PubMed 17551264Dellinger 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.
- Background: PubMed 18022081Kramer 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.
- Background: PubMed 18716118Yigla 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.
- Background: PubMed 19085584Guntupalli 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.
- Background: PubMed 19065052Becker 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.
- Background: PubMed 17873167Colice 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank C Detterbeck, MD principal investigator
Yale University Medical School
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Deep Breeze at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of ppo FEV1 and ppo DLCO as predicted by VRI with the values as predicted by Q scan (time frame: Prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966511, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2011.