Trial Information

3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate

Part 1:

Prostate cancer tissue has certain differences in its metabolism (chemical makeup) that are
not seen in normal tissue. 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
body regions, MRSI shows the metabolic features of the prostate cells. MRSI exams that use
a "coil" behind the prostate (inside of the rectum) have been used to measure the metabolic
features of prostate cancer tissue. This has been shown to improve the accuracy of finding
prostate tumor using standard scanners called "1.5T" scanners.

The coil works like an antenna, and air is normally used inside the coil to inflate it. The
accuracy of endorectal MRSI exams still needs improvement. Use of PFC instead of air inside
of the coil has been shown to greatly improve the quality of MRSI images at 1.5T scanners.
At first, researchers want to learn if the newer, stronger (3T) scanners will improve the
quality of endorectal MRSI exam when combined with PFC within the coil. PFC is a clear and
odorless liquid that, as opposed to air, is physically very similar to human tissue (such as
prostate tissue). This makes the MRSI images much clearer.

If you agree to take part in this study (Part 1) and are found to be eligible, you will have
2 MRSI exams (one with air and one with PFC) using an endorectal coil.

Before being inserted, the coil will be inflated with air to check for a possible leak. 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 exam can be completed. Once the first MRSI exam is completed, as much of the air
as possible will be removed from the coil using a syringe.

The coil will then be filled with PFC, and the second MRSI exam will be repeated in the same
manner. At the end of the exam, the PFC will be removed in the same manner, and then the
coil will be removed from the rectum. There will be no direct contact between the PFC or
air inside the coil and your body. In total, the 2 MRSI studies should take about 60
minutes.

You will have a prostatectomy (surgical removal of the prostate) within 3 months of having
the MRSI exams performed. After the operation, your participation in this study will be
over.

Part 2:

If you agree to take part in this study (Part 2) and are found to be eligible, you will have
an MRSI exam with PFC using an endorectal coil. Only PFC will be used.

Before being inserted, the coil will be inflated with air to check for a possible leak, and
as much as possible of the air will be removed. 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 PFC, and you will lie on your back so the MRSI exam can be completed. Once the
exam is completed, the PFC will be removed from the coil using a syringe and then the coil
will be removed from the rectum. There will be no direct contact between the PFC inside the
coil and your body. The procedure should take about 30 minutes.

You will have a prostatectomy (surgical removal of the prostate) within 3 months of having
the MRSI exam performed. After the operation, your participation in this study will be
over.

This is an investigational study. The 3T scanners, software, and hardware used for this
study are FDA-approved and being used in clinical practice. PFC has not yet been approved
for use in endorectal MRSI exams. MRSI scans are commercially available and FDA-approved
for routine clinical care. You will not be charged for the MRSI exam. Up to 80 patients
(40 in this second part of the study and 40 in Part 1) will take part in this study. All
will be enrolled at MD Anderson.