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Vibration Response Imaging (VRI) in Patients Who Are Candidates for Undergoing Surgical Resection Due to Lung Cancer or Other Intrathoracic Malignancy


N/A
18 Years
90 Years
Not Enrolling
Both
Lung Cancer

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Trial Information

Vibration Response Imaging (VRI) in Patients Who Are Candidates for Undergoing Surgical Resection Due to Lung Cancer or Other Intrathoracic Malignancy


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.


Inclusion Criteria:



1. Able and willing to read, understand, and provide written Informed Consent, and

2. Male or Female in the age range 18-90 years, and

3. Referred to perform QRRVP test for pre lung surgery evaluation due to lung cancer or
other intrathoracic malignancy, and

4. BMI (body mass index) equal to or greater than 19

Exclusion Criteria:

1. Chest wall deformation, or

2. Spine deformation (including severe scoliosis), or

3. Hirsutism on back, or

4. Potentially contagious skin lesion on the back, or

5. Skin lesion that would interfere with sensor placement, or

6. Cardiac pacemaker or implantable defibrillator

7. Pregnancy (all women of childbearing age must have a negative pregnancy test before
beginning the study) or breast feeding

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

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.

Outcome Time Frame:

4 Years

Safety Issue:

No

Principal Investigator

Rodolfo C. Morice, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0668

NCT ID:

NCT00506467

Start Date:

November 2006

Completion Date:

August 2009

Related Keywords:

  • Lung Cancer
  • Intrathoracic Malignancy
  • Lung Cancer
  • Vibration Response Imaging
  • VRI
  • Lung Neoplasms

Name

Location

U.T.M.D. Anderson Cancer CenterHouston, Texas  77030