Trial Information

Phase I Assessment of Thermal Signature of Patients Undergoing Radiation Therapy

For Patients:

THERMAL IMAGER:

A thermal imager (a camera similar to a digital camera) takes pictures of skin surfaces. The
imager is able to view temperature distribution of the skin surface.

STUDY PARTICIPATION:

If you agree to take part in this study, your body temperature will be measured with thermal
imaging.

You will have thermal imaging sessions several times before the cancer treatment starts and
during the therapy course. You will be given detailed instructions on how to prepare for the
imaging sessions ahead of time as well as what to expect during the imaging sessions.

Before beginning thermal imaging, your temperature will be measured with a thermometer. To
perform thermal imaging, you will be asked to take off all of your clothes in a private room
and stand still in front of a thermal imaging camera. No one will be present while you
disrobe. When you have finished taking off your clothes a radiation oncologist or other
medical doctor will record several pictures from a computer stationed outside the room.
Pictures of your front, back, and side views will be taken. These pictures will look like a
silhouette (body outline) with thermal coloring. The entire imaging session should take
about 10 minutes to complete each time.

LENGTH OF STUDY:

Your participation will be over in this study after the thermal images have been recorded.

This is an investigational study. Thermal imaging is FDA approved and commercially
available for breast cancer screening. Its use in this study is investigational. Up to 35
patients will take part in this study. All will be enrolled at M. D. Anderson.

For Volunteers:

THERMAL IMAGER:

A thermal imager (a camera similar to a digital camera) takes pictures of skin surfaces. The
imager is able to view temperature distribution of the skin surface.

STUDY PARTICIPATION:

If you agree to take part in this study, your body temperature will be measured with thermal
imaging.

You will have thermal imaging sessions several times during the course of this study. You
will be given detailed instructions on how to prepare for the imaging sessions ahead of time
as well as what to expect during the imaging sessions.

Before beginning thermal imaging, your temperature will be measured with a thermometer. To
perform thermal imaging, you will be asked to take off all of your clothes in a private room
and stand still in front of a thermal imaging camera. No one will be present while you
disrobe. When you have finished taking off your clothes a radiation oncologist or other
medical doctor will record several pictures from a computer stationed outside the room.
Pictures of your front, back, and side views will be taken. These pictures will look like a
silhouette (body outline) with thermal coloring. The entire imaging session should take
about 10 minutes to complete each time.

Volunteers will not participate in any part of cancer treatment, diagnostic imaging tests
(CT, PET, etc), or any other clinical procedures in MD Anderson. Volunteers will not need to
see physicians at MD Anderson or elsewhere. Thermal images will be taken 4 times during one
day for a volunteer (morning, midmorning, earlier afternoon, late afternoon). Volunteers
should not take any medications or perform any other medical procedures from morning to late
afternoon until the thermal imaging is completed.

LENGTH OF STUDY:

Your participation will be over in this study after the thermal images have been recorded.

This is an investigational study. Thermal imaging is FDA approved and commercially
available for breast cancer screening. Its use in this study is investigational. Up to 10
volunteers without cancer (5 males and 5 non-pregnant females) will take part in this study.
All will be enrolled at M. D. Anderson.