Trial Information

Assessment of the Reliability of Implanted Fiducials for Tracking of Respiratory-Induced Tumor Motion

If you are eligible to take part in this study, you will have pulmonary (lung) function
testing. This testing will involve your breathing through a mouthpiece and measuring the
amount of air you breathe. This will provide information on how well your lungs work, and
how your chest wall moves when you breathe.

You will then begin the normal treatment planning process. A bean-bag "cast" will be made
for you to lie in during planning and treatment. This is done to lower day-to-day changes
in your position. A CT scan will be taken with you breathing quietly, and possibly several
X-rays will be performed as well. You will be marked with magic marker, and possibly have
several permanent tattoos placed to help with daily positioning. These procedures normally
take 1-2 hours.

Small metal markers (up to 5) will then be placed near your tumor. A thin, flexible tube
with a camera, called a bronchoscope, will be used to place these markers in your lungs. You
will be given a sedative through one of your veins and a local anesthetic will be sprayed in
your nose and mouth before introducing the bronchoscope. The bronchoscope is introduced
through one of your nostrils and then passed into your windpipe and bronchial tubes. This
will allow the doctor to examine your lungs and place the small metal markers. These
markers will be used to track the tumor during treatment. In this way the radiation
treatment can be given to the tumor even if it moves while you breathe.

You will also have studies to measure how much the tumor moves. This will be done with
several additional CT scans, typically taken on a weekly basis. Additional pulmonary
function measurements will be taken during the CT scans. These measurements will allow
researchers to monitor the movement of your tumor when you breathe. These procedures will
normally take between 1 and 2 hours.

You will be on this study for the duration of your radiation treatments. You will be
followed up an for an additional 4 - 6 weeks to make sure there are no complications from
the study.

THIS IS AN INVESTIGATIONAL STUDY. A total of up to 30 patients will take part in this
study. All will be enrolled at M. D. Anderson.