Lung CancerNCT00506467
Vibration Response Imaging (VRI) in Lung Cancer Patients
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: To estimate the accuracy of the pre-operative VRI QRF (Quantitative Regional Function) results versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion) pre-operative scan. 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?
- Vibration Response Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Aug 2009
- 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: Patients diagnosed with lung cancer or other intrathoracic malignancy.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Vibration Response Imaging (VRI) in Patients Who Are Candidates for Undergoing Surgical Resection Due to Lung Cancer or Other Intrathoracic Malignancy
Primary Objective:
- To estimate the accuracy of the pre-operative VRI QRF (Quantitative Regional Function) results versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion) pre-operative scan.
Secondary Objective:
- 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.)
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.
This is an investigational study. The VRI system is not FDA approved or commercially available for use in the United States. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- Vibration Response Imaging
- Keywords
- Intrathoracic Malignancy, Lung Cancer, Vibration Response Imaging, VRI
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration Response ImagingProcedure or surgery
Lung function test performed using the VRI system immediately before or after the standard lung function test.
| Study group | Role | What they receive |
|---|---|---|
| VRI System | Vibration Response Imaging (VRI) System Receives: Procedure: Vibration Response Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To learn the level of accuracy of pre-surgery results from the Vibration Response Imaging (VRI) system compared with the results from the standard pre-surgery lung function test that is performed on patients with lung cancer or cancer in the chest.
Measured: 4 Years
Secondary outcomes (1)
To learn the level of accuracy of the VRI system in predicting how the lungs will function after surgery.
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startNov 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Deep Breeze
- Responsible party
- Sponsor
- Investigators
- Rodolfo C. Morice, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506467
- Sponsor's protocol ID
- 2006-0668
- Status last verified
- Jul 2012
- First submitted
- 24 Jul 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Response Imaging (VRI) in Patients Who Are Candidates for Undergoing Surgical Resection Due to Lung Cancer or Other Intrathoracic Malignancy
- ClinicalTrials.gov ID
- NCT00506467
- Acronym / sponsor ID
- 2006-0668
- Conditions
- Lung Cancer
- Keywords
- Intrathoracic Malignancy, Lung Cancer, Vibration Response Imaging, VRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Deep Breeze
- Study start
- Nov 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Jul 2007 (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.
Primary Objective:
- To estimate the accuracy of the pre-operative VRI QRF (Quantitative Regional Function) results versus the gold standard QRRVP (Quantitative Radionuclide Study of Regional Lung Ventilation and Perfusion) pre-operative scan.
Secondary Objective:
- 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.)
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.
This is an investigational study. The VRI system is not FDA approved or commercially available for use in the United States. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRI System | – | Procedure: Vibration Response ImagingVibration Response Imaging (VRI) System |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with lung cancer or other intrathoracic malignancy.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration Response ImagingLung function test performed using the VRI system immediately before or after the standard lung function test. | Procedure or surgery | VRI System |
Primary outcome
To learn the level of accuracy of pre-surgery results from the Vibration Response Imaging (VRI) system compared with the results from the standard pre-surgery lung function test that is performed on patients with lung cancer or cancer in the chest.
Time frame: 4 Years
1 secondary outcome
To learn the level of accuracy of the VRI system in predicting how the lungs will function after surgery.
Time frame: 4 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Rodolfo C. Morice, MD principal investigator
M.D. Anderson Cancer Center
1 site 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 M.D. Anderson Cancer Center at 1 site 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 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: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To learn the level of accuracy of pre-surgery results from the Vibration Response Imaging (VRI) system compared with the results from the standard pre-surgery lung function test that is performed on patients with lung cancer or cancer in the chest. (time frame: 4 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2012.