Vibration Response Imaging (VRI) in Lung Cancer Patients
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

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.)
    

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.
    

Intervention name(s): Vibration Response Imaging
Intervention type(s): Procedure
Intervention description(s): Lung function test performed using the VRI system immediately before or after the standard lung function test.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with lung cancer or other intrathoracic malignancy.
      
Keywords: Intrathoracic Malignancy; Lung Cancer; Vibration Response Imaging; VRI