Trial Information

Feasibility of Combined CT Colonography and PET Imaging for Detection of Colonic Involvement by Mantle Cell Lymphoma

Colonoscopy Testing:

A colonoscopy is a routine test where the doctor looks at the inner lining of the colon
using a long, flexible, lighted tube that is inserted through the anus. This is the
standard procedure for detecting mantle cell lymphoma in the colon.

PET/CT Scanning:

Because PET/CT scanning is less invasive than colonoscopy, researchers want to learn more
about whether PET/CT scanning may be able to be used for detecting mantle cell lymphoma in
the colon.

PET/CT scanning is also considered a routine test for checking the status of mantle cell
lymphoma. The scan is called "full body" because the neck, chest, abdomen (stomach area),
and pelvis are included.

In this study, participants will have a full-body PET/CT procedure performed like they
normally would, but the difference will be that gas will be pumped into the colon before the
scan. This is so the colon will be opened up (inflated) so the study doctor will be able to
more easily look for any lesions. The procedure is called gas insufflation. (In standard
PET/CT scanning of the colon, gas insufflation is not used.)

Study Participation:

If you agree to take part in this study, you will begin the PET/CT procedure, as usual.
This means a special substance called fluorodeoxyglucose will be injected by vein, in order
to make the tumor more visible in the scanned image.

About an hour later, the study doctor will prepare your colon for the PET/CT scan by
performing gas insufflation. To do so, a soft plastic tube will be inserted through your
anus. Carbon dioxide gas will be automatically pumped into your colon until the gas is at
the correct pressure.

If the study doctor decides it is necessary (for example, if cramping occurs), you will
receive a glucagon injection under the skin in order to relax the colon. Glucagon is a
medication that helps to relax the colon and decrease cramping. If continued cramping
occurs, the gas will be turned off which results in immediate relief. This is considered
routine for the CT part of the PET/CT. Administering the gas for the CT is similar to the
sensation that will be felt during the colonoscopy when the colon is also insufflated.

After the gas insufflation, the routine PET/CT scan will be performed to check the status of
the disease. You will lie on your stomach for the first part of the PET/CT scan and on your
back for the second part.

After the PET/CT scan, the routine colonoscopy will be performed. You will need to sign a
separate consent form for the colonoscopy, and the procedure will be explained to you in
detail.

Length of Study:

Your participation in this study will be over after the PET/CT scan. Researchers will
compare the results of the PET/CT scan to the results of the colonoscopy.

This is an investigational study. Gas insufflation and glucagon are FDA approved for use
with CT colonography (colonoscopy that uses CT scanning), which is typically used to screen
for colon cancer. PET/CT scanning is FDA approved for use in checking the status of mantle
cell lymphoma. Using PET/CT scanning to detect mantle cell lymphoma in the colon, however,
is investigational. For this purpose, at this time PET/CT scanning is being used in
research only.

Up to 43 patients will take part in this study. All will be enrolled at M. D. Anderson.