Trial Information

Phase II Trial Comparing 4-Dimensional Computed Tomography Derived Ventilation Versus SPECT/CT Tc-99m Aerosol Ventilation in Patients With Thoracic Malignancies

By using a 4-dimensional (4D) computed tomography (CT) scans researchers will create
ventilation (circulation of air) calculations. This new calculation method is quicker and
may produce better images than the standard ventilation calculations.

Before you can start this study, you may have a "screening test." This test will help the
doctor decide if you are eligible to take part in this study. Women who are able to have
children must have a negative blood (about 2 teaspoons) pregnancy test.

If you agree to take part in this study and are found to be eligible, you will have lung
function imaging. Lung function imaging gives researchers information on how well the lungs
work, how air moves into the lungs with breathing, and blood circulation into the lungs.

You will have three 4D CT scans performed while you are breathing quietly. A 2-inch plastic
box will be placed on top of your chest to monitor the motion of your chest during the
scanning. After you are out of the CT scanner (once the scanning is finished), ventilation
images are calculated from the 4D CT images and will be compared with the standard
ventilation imaging method. The 4D CT imaging will take about 30 minutes to complete.

As part of standard care, once you have finished the 4D CT scan, you will have a single
photon emission computed tomography (SPECT) pulmonary (lung) ventilation scan performed. The
SPECT ventilation scan requires that you first breathe in a radioactive aerosol (or mist,
called Tc-99m DPTA), which will help the study doctor tell where air goes when you breathe.
Then you will be placed in the SPECT scanner, and images will be taken of your lungs. The
SPECT imaging will take about 1 hour to complete.

Within 10 days after the first imaging session, you will return for a second imaging
session. During the second imaging session, you will have a standard of care SPECT
pulmonary perfusion (blood supply to tissue and organs) test done. During this test, a
radioactive substance is given by vein (called Tc-99m MAA). This substance will get trapped
in the lungs, and the SPECT imaging will show the blood flow in the lungs. This test should
take 45-60 minutes to complete.

Once you complete the second imaging session, your participation will over in this study.

This is an investigational study. All of the imaging scans used in this study are FDA
approved and commercially available. The calculation of ventilation images from 4D CT
scanning is investigational and authorized for use in research only. Up to 36 patients will
take part in this study. All will be enrolled at M. D. Anderson.