FLT-PET as an Imaging Biomarker in Patients Receiving the Combination of Cell Cycle Inhibitors Temsirolimus, Topotecan, and Bortezomib
An FLT-PET scan uses the FLT solution, which contains a small amount of radioactive
material, to help locate cancer cells inside the body. This scan may help doctors find
solid tumors as well as learn if these tumors are growing and how fast they are growing.
This information could be used to help predict if the cancer will respond to treatment.
Within 2 weeks before Day 1 of Cycle 1 and between Days 19 and 21 of Cycle 1, you will have
a FLT-PET scan.
For at least 4 hours before the FLT-PET scan, you must not eat or drink anything. You will
receive the FLT solution by vein. The FLT solution is a mildly radioactive material. The
radioactive nature of the solution allows the scanner to "see" it in certain places in your
body. After the injection, you will need to rest quietly until it is time for the scan.
The amount of rest time may vary, but be prepared to wait for about 60 minutes. During the
scan, you will lie flat on your back on a table. After the solution is injected into a vein,
the PET scanner takes pictures of the radioactive solution as it moves through the body and
collects at various sites in the body. By watching how the solution travels through the
body and studying where the solution collects, researchers can learn the status of disease
in the body. The scan itself may last about 40-60 minutes.
Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be
measured before each injection of the FLT solution, 30 minutes after each injection, and
before each PET scan. You will be allowed to leave 30 minutes after your scan, if your
vital signs are acceptable.
Length of Study:
You will be off this study after the second FLT-PET scan. You will be taken off study early
if you have intolerable side effects or the study doctor thinks it is in your best interest.
This is an investigational study. The FLT solution is not FDA approved or commercially
available. At this time, FLT solution is only being used in research.
Up to 5 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Standardized Uptake Value (SUV)
SUV measured on continuous scale at two specified time points (baseline and post-treatment phase, cycle 1, day 19-21).
Cycle 1, Day 21
Sarina Piha-Paul, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|