Vibration Response Imaging (VRI) in the Preoperative Management in Patients With Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00845143|
Recruitment Status : Unknown
Verified February 2009 by Heidelberg University.
Recruitment status was: Active, not recruiting
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
|Condition or disease|
|Non-Small Cell Lung Cancer Lung Function|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||Vibration Response Imaging (VRI) in the Preoperative Management in Patients With Non-Small Cell Lung Cancer|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||February 2011|
|Estimated Study Completion Date :||August 2011|
- lung function testing diffusion capacity VRI [ Time Frame: pre- 6 weeks post and 3 month postoperative ]