Fluoro-L-Thymidine Positron Emission Tomography (FLT PET) vs. Adv. Magnetic Resonance (MR) Techniques in Recurrent Glioma



Status:Not yet recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/11/2015
Start Date:September 2015
Contact:Eric Rohren, MD, PHD
Phone:713-792-8443

Use our guide to learn which trials are right for you!

Pilot Study to Assess Accuracy of Time-resolved FLT PET and MR Techniques in Determining Treatment-related Necrosis From Recurrent Glioma

The goal of this clinical research study is to learn if using a new imaging solution,
3'-Deoxy-3'-18f-Fluorothymidine, in a positron emission tomography (PET) scan can help
doctors determine if your brain lesion is from the tumor returning or the effects of
previous treatments.

The results of this imaging scan (called an FLT PET scan) will be compared to the results of
a Magnetic Resonance Imaging scan, which you have already had or are scheduled to have
outside of this study.

FLT PET Scan:

If you are found to be eligible to take part in this study, you will have an FLT PET scan.

An FLT PET scan uses the 3'-Deoxy-3'-18f-Fluorothymidine solution, which contains a small
amount of radioactive material. The radioactive nature of the solution allows the scanner to
"see" it in certain places in your body. You will receive the solution by vein through a
catheter. A central venous catheter is a sterile flexible tube that will be placed into a
large vein while you are under local anesthesia. Your doctor will explain this procedure to
you in more detail, and you will be required to sign a separate consent form.

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 may be able to learn where the
disease is in your body. The entire procedure should last about 60-70 minutes.

You must not eat or drink anything except water for at least 6 hours before the FLT PET
scan.

About 2 minutes after the FLT solution is injected, blood (about 10 teaspoons) will be drawn
from the catheter. This blood will be drawn to measure how much FLT is in your body and may
help the study staff understand the images better.

Length of Study:

After the FLT PET scan is complete, your active participation on this study will be over.

Follow-Up Medical Record Review:

About 30 days after the FLT PET scan, you will be contacted by phone by the study staff to
check if you are having any side effects. The phone call should last about 15 minutes.

Your medical records will continue to be reviewed for up to an additional 5 years to learn
how you are doing, what other treatments you may have had and how they worked, if you had
any new brain problems, or if the tumor came back.

This is an investigational study. The 3'-Deoxy-3'-18f-Fluorothymidine solution is not FDA
approved or commercially available. At this time, 3'-Deoxy-3'-18f-Fluorothymidine solution
is only being used in research.

Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patient is >/= 18 years old, agrees to participate in the clinical study and to
complete all required visits and evaluations. The pediatric population has a
different disease profile from the glioma patients we hope to recruit. To reduce
heterogeneity in the patient population we will not consider patients younger than 18
for this study.

2. Patient is a candidate for cerebral tumor resection due to an enhancing brain lesion,
with history of previous pathologically proven primary brain tumor (WHO grade II-IV
diffuse glioma)

3. Patient had diffuse glioma (WHO grade 2 - 4) and as part of their treatment received
radiation therapy and Temozolomide (a first-line chemotherapeutic agent).

4. Patient will have subsequently developed an enhancing brain mass greater than 1cm in
diameter, at least 6 months after finishing radiation therapy (to differentiate from
the more acute treatment related effect of "pseudo-progression").

5. As the predominate means of determining TRN versus recurrent glial tumor at MD
Anderson, a brain tumor/ necrosis protocol is ordered as clinically indicated.

6. Patient's clinician based on the clinical and MR information wants to proceed with
biopsy or surgical resection within 30 days from when the brain tumor MR protocol was
performed. The patient meets with the neurosurgeon and agrees to surgical biopsy or
resection.

7. Patient is able to understand and give consent to participation in the study

8. Patient has received as part of their care the Brain Tumor Imaging protocol.

9. Patient agrees to undergo, prior to the procedure, FLT PET at CABI

Exclusion Criteria:

1. The patient is found to have unfavorable anatomy to indicate that stereotactic
biopsy/ resection could not be safely performed

2. Claustrophobia that does not readily respond to oral medication

3. Allergy to Fluoro-L-Thymidine

4. Pregnant or lactating (Based on self-reported and clinical care testing with
physicians before study participation)
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
?
mi
from
Houston, TX
Click here to add this to my saved trials