Trial Information

Feasibility Study of 3T Endorectal Magnetic Resonance Spectroscopic Imaging (MRSI) of Prostate

MRSI is a type of magnetic resonance imaging (MRI) that uses the same type of scanner as a
standard MRI. Unlike standard MRI, which takes pictures of the anatomy (body regions), MRSI
takes pictures of the metabolic features of the body. Prostate cancer tissue has certain
differences in its metabolism (chemical makeup) that are not seen in normal tissue. MRSI is
used to detect prostate tumors by measuring the metabolic features, and an endorectal
(inside of the rectum) coil is used. The coil is like an antenna.

Endorectal coils inflated with air are commonly used to detect prostate tumors and measure
the status of the disease using a 1.5T (lower-powered, standard clinical) scanner. However,
the accuracy of endorectal MRSI scanning still needs improvement. Researchers want to find
out if the quality of endorectal MRSI scanning can be improved by using a stronger (3T)
scanner and/or using PFC in the endorectal coil instead of air. PFC is a clear and odorless
liquid that is known to be virtually non-toxic to the human body. It has been used as an
oral contrast (swallowed by mouth) for standard MRIs. As opposed to air, PFC is physically
very similar to prostate tissue, which may improve the quality of the MRSI images.

If you agree to take part in this study, you will have 2 endorectal MRSI studies (one with
air and one with PFC). The MRSI study with air is diagnostic and considered standard of
care, and the MRSI study with PFC is investigational. Before being inserted into your
rectum, the coil will be filled with air in order to test for any leakage. You will lie on
one side, inside of a 3T MRI scanner, and the coil (covered with protective latex) will be
inserted into your rectum. Having the coil inserted is similar to having an enema tip
inserted. The coil will be filled with air, and you will lie on your back so the first MRSI
study can be completed. The study doctor will carefully check the coil to be sure it is
centered at the right place to cover the entire prostate.

After the first MRSI study is completed, the air will be removed using a syringe. The coil
will then be filled with PFC, and the second MRSI study will be repeated in the same manner.
Once both studies are completed, the coil will be removed after the PFC is removed from the
coil. There will be no direct contact between the air or PFC within the coil and your body.
In total, the 2 MRSI studies should take about 60 minutes.

After the MRSI studies are completed, researchers will study the information with a special
computer to compare the technical quality of the 2 sets of MRSIs. Your participation in
this study will be over. Your doctor will receive a report of your diagnostic exam (the
MRSI study with air).

This is an investigational study. 3T scanners and the software for routine MRI used for
this study are FDA-approved. The use of air in the endorectal coil is a standard procedure.
MRSI/MRI equipment for a 1.5T scanner is commercially available and FDA-approved for
routine clinical care. PFC used for this study and the software for MRSI acquisition at a
3T scanner have not been FDA-approved. Up to 20 patients will take part in this study.
All will be enrolled at M. D. Anderson.