Non-Small Cell Lung CancerNCT00845143
Vibration Response Imaging (VRI) in the Preoperative Management in Patients With Non-Small Cell Lung Cancer
An observational study of Non-Small Cell Lung Cancer and Lung Function, run by Heidelberg University.
Trial summary
The purpose of this study is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (FEV1 and DLCO) in patients who underwent surgical resection (FEV1 = Forced expiratory volume in 1-second. DLCO = Diffusion capacity for carbon monoxide. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Lung Function
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Aug 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with operable non-small cell lung cancer
Who may be able to join
- Able and willing to read, understand, and provide written Informed Consent, and
- Male or Female in the age range 18-90 years, and
- Referred to perform QRRVP test for pre lung surgery evaluation due to lung cancer or other intrathoracic malignancy, and
- BMI (body mass index) equal to or greater than 19
Who cannot join
- Chest wall deformation, or
- Spine deformation (including severe scoliosis), or
- Hirsutism on back, or
- Potentially contagious skin lesion on the back, or
- Skin lesion that would interfere with sensor placement, or
- Cardiac pacemaker or implantable defibrillator
- Pregnancy (all women of childbearing age must have a negative pregnancy test before beginning the study) or breast feeding
About this study
The purpose of this study is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (FEV1 and DLCO) in patients who underwent surgical resection (FEV1 = Forced expiratory volume in 1-second. DLCO = Diffusion capacity for carbon monoxide. ppo = predicted postoperative.)and versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion)
Read the detailed description
The current standard lung function test uses radioisotopes (materials that produce radiation) injected in a vein and breathed into the lungs, which can show images of the function of the lungs.
The VRI system uses pressure sensors that act like electronic stethoscopes (tools used by doctors to listen to the heart and other sounds in the body). These sensors can record the energy (vibrations) created by the airflow in the lungs during the breathing process, which can then be visually imaged.
Before you can start this study, there will be a screening evaluation. The study doctor will review your medical record to find out if you are eligible to take part in this study. Information that will be viewed will include whether you have a skin lesion that might interfere with sensor placement, whether you have a cardiac pacemaker, and/or pregnancy test results. The study doctor will review with you the other types of information that will be viewed from your medical record to find out if you are eligible to take part in this study. For women who are able to have children, if you do not have a negative pregnancy test result in your medical record, you will not be able to take part in this study.
If you are found to be eligible and you agree to take part in this study, you will have a lung function test with the VRI system immediately before or after the standard lung function test. To perform the VRI test, you will be asked to remove your shirt and put on a garment to cover the front of your body. You will also be asked to remove your jewelry and other body accessories. You will then be asked to sit on a backless chair, and you will be instructed how to sit with the proper posture and breathe correctly for this test.
Before recording starts, the sensors will be cleaned and then placed on your back. You will be instructed to breathe deeply for up to 12 seconds (about 2-3 times), and the vibration responses will be recorded. You will have a total of 3 recording sessions, one after the other. Once all the recording is done, the sensors will be removed. The VRI image of the vibrations will then be examined by the operator in order to check the quality of the image.
The signals recorded from the sensors will be transferred to a computer so that researchers can study the images. The results of the recordings will be compared with the standard lung function test results. This will help researchers learn the level of accuracy of the VRI system in predicting how the lungs will function after surgery.
You will not be told of the results from the VRI testing because the results will not be used to diagnose your medical condition, nor will any medical decisions be made based on the VRI results. The VRI system is only used for investigational purposes in this study and will not replace the current diagnostic methods.
If you undergo surgery, as part of your standard care, you will also return to the clinic for standard tests to check your lung function 4-12 weeks and 4-12 months after your surgery. Researchers will compare your pre-surgery test results (both the standard test results and the VRI results) with the results of the tests after surgery (standard tests) to learn the level of accuracy of the VRI system in predicting how the lungs will function after surgery.
- Conditions
- Non-Small Cell Lung Cancer, Lung Function
- Keywords
- Non-small cell lung cancer, surgery, lung function
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
lung function testing diffusion capacity VRI
Measured: pre- 6 weeks post and 3 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845143
- Sponsor's protocol ID
- 003 HD
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18716118Benditt JO. Surgical therapies for chronic obstructive pulmonary disease. Respir Care. 2004 Jan;49(1):53-61; discussion 61-3.
PubMed 14733622Kristersson S, Lindell SE, Svanberg L. Prediction of pulmonary function loss due to pneumonectomy using 133 Xe-radiospirometry. Chest. 1972 Dec;62(6):694-8. doi: 10.1378/chest.62.6.694. No abstract available.
PubMed 4635418Guntupalli 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 19085584
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Response Imaging (VRI) in the Preoperative Management in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00845143
- Acronym / sponsor ID
- 003 HD
- Conditions
- Non-Small Cell Lung Cancer, Lung Function
- Keywords
- Non-small cell lung cancer, surgery, lung function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 18 Feb 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 purpose of this study is to assess the correlation of the predicted post-operative lung function with the observed post-operative lung function (FEV1 and DLCO) in patients who underwent surgical resection (FEV1 = Forced expiratory volume in 1-second. DLCO = Diffusion capacity for carbon monoxide. ppo = predicted postoperative.)and versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion)
Detailed description
The current standard lung function test uses radioisotopes (materials that produce radiation) injected in a vein and breathed into the lungs, which can show images of the function of the lungs.
The VRI system uses pressure sensors that act like electronic stethoscopes (tools used by doctors to listen to the heart and other sounds in the body). These sensors can record the energy (vibrations) created by the airflow in the lungs during the breathing process, which can then be visually imaged.
Before you can start this study, there will be a screening evaluation. The study doctor will review your medical record to find out if you are eligible to take part in this study. Information that will be viewed will include whether you have a skin lesion that might interfere with sensor placement, whether you have a cardiac pacemaker, and/or pregnancy test results. The study doctor will review with you the other types of information that will be viewed from your medical record to find out if you are eligible to take part in this study. For women who are able to have children, if you do not have a negative pregnancy test result in your medical record, you will not be able to take part in this study.
If you are found to be eligible and you agree to take part in this study, you will have a lung function test with the VRI system immediately before or after the standard lung function test. To perform the VRI test, you will be asked to remove your shirt and put on a garment to cover the front of your body. You will also be asked to remove your jewelry and other body accessories. You will then be asked to sit on a backless chair, and you will be instructed how to sit with the proper posture and breathe correctly for this test.
Before recording starts, the sensors will be cleaned and then placed on your back. You will be instructed to breathe deeply for up to 12 seconds (about 2-3 times), and the vibration responses will be recorded. You will have a total of 3 recording sessions, one after the other. Once all the recording is done, the sensors will be removed. The VRI image of the vibrations will then be examined by the operator in order to check the quality of the image.
The signals recorded from the sensors will be transferred to a computer so that researchers can study the images. The results of the recordings will be compared with the standard lung function test results. This will help researchers learn the level of accuracy of the VRI system in predicting how the lungs will function after surgery.
You will not be told of the results from the VRI testing because the results will not be used to diagnose your medical condition, nor will any medical decisions be made based on the VRI results. The VRI system is only used for investigational purposes in this study and will not replace the current diagnostic methods.
If you undergo surgery, as part of your standard care, you will also return to the clinic for standard tests to check your lung function 4-12 weeks and 4-12 months after your surgery. Researchers will compare your pre-surgery test results (both the standard test results and the VRI results) with the results of the tests after surgery (standard tests) to learn the level of accuracy of the VRI system in predicting how the lungs will function after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with operable non-small cell lung cancer
Key inclusion criteria (4 listed)
- Able and willing to read, understand, and provide written Informed Consent, and
- Male or Female in the age range 18-90 years, and
- Referred to perform QRRVP test for pre lung surgery evaluation due to lung cancer or other intrathoracic malignancy, and
- BMI (body mass index) equal to or greater than 19
Key exclusion criteria (7 listed)
- Chest wall deformation, or
- Spine deformation (including severe scoliosis), or
- Hirsutism on back, or
- Potentially contagious skin lesion on the back, or
- Skin lesion that would interfere with sensor placement, or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lung function testing diffusion capacity VRI
Time frame: pre- 6 weeks post and 3 month postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
- 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 14733622Benditt JO. Surgical therapies for chronic obstructive pulmonary disease. Respir Care. 2004 Jan;49(1):53-61; discussion 61-3.
- Background: PubMed 4635418Kristersson S, Lindell SE, Svanberg L. Prediction of pulmonary function loss due to pneumonectomy using 133 Xe-radiospirometry. Chest. 1972 Dec;62(6):694-8. doi: 10.1378/chest.62.6.694. No abstract available.
- Results publication: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and Lung Function, run by Heidelberg University.
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 7 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 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
lung function testing diffusion capacity VRI (time frame: pre- 6 weeks post and 3 month postoperative). 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 NCT00845143, which also lists 4 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 18 Feb 2009.