Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506467
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-07-24
Brief Title:
Vibration Response Imaging VRI in Lung Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Vibration Response Imaging VRI in Patients Who Are Candidates for Undergoing Surgical Resection Due to Lung Cancer or Other Intrathoracic Malignancy
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None