A Phase I Study of 18-F-Fluoroacetate Sodium as a PET Imaging Agent for Tumor Detection
The Study Solution:
18-F-fluoroacetate sodium is designed to be attracted to cells that grow in some tumors.
This imaging solution has a small dose of radiation added to it, which may help the doctor
to "see" cancer cells and their possible spread through the body, during the scans. This is
the first study using 18-F-fluoroacetate sodium in humans.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to an
imaging study date. The first group of 6 participants will receive a smaller dose of
solution (less than one half of the regular PET scan tracer radioactivity). The later 2
groups may receive the same dose of solution or a larger dose, but the larger dose will
still be no more than what you would receive in a regular clinic PET scan procedure.
Study Solution Administration and PET Scans:
On Day 1, you will receive 18-F-fluoroacetate sodium by vein over 5 minutes.
You will then have 3 PET scans with a PET/CT scanner. You will be lying down during the PET
scan. Each scanning period will take about 1 hour. You will have a 20-minute rest period
between each scan.
Before each PET scan, you will have a CT scan, called a "Scout View", to check your position
in the machine. This should take about 5 minutes.
You may continue receiving standard treatment from your regular doctor throughout the entire
time you are in this study.
Study Visits:
On Day 1 (the day of the injection and imaging study):
- You will have an ECG, your vital signs will be measured, and the injection site will be
checked at 5 minutes before, and 30 minutes and 2 ½ hours after the imaging solution is
injected.
- You will be asked if you have had any side effects.
- Blood (about 2 tablespoons total) will be drawn 9 times over 2 ½ hours after the
injection for pharmacokinetic (PK) testing. PK testing measures the amount of the
imaging solution in the body at different time points.
- Urine will also be collected to test the amount of radiation that might have been
absorbed by the body. This will be collected during the 10 minute rest periods.
On Day 2:
- Your vital signs will be measured.
- You will have an ECG.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- The injection site will be checked.
- You will be asked if you have had any side effects.
On Day 7:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- The injection site will be checked.
- You will be asked if you have had any side effects.
On about Day 30:
- You will have a physical exam, including measurement of your vital signs.
- You will have an ECG.
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- The injection site will be checked.
- You will be asked if you have had any side effects.
Length of Study:
You will be on active study for the day you receive the imaging and 18-F-fluoroacetate
sodium. You will be on follow-up for up to 30 days after the imaging.
This is an investigational study. 18-F-fluoroacetate sodium is not FDA approved or
commercially available. At this time, it is being used in research only. The study scans
are also considered investigational when used for this purpose, and will not be used for
planning your cancer treatment.
Up to 18 patients will take part in this study. All will be enrolled at M. D. Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Biodistribution of 18F-Fluoroacetate
Biodistribution of 18F-fluoroacetate is measured during imaging, using a radioisotope (18F) of fluoroacetate PET scan. The percent injected dose (%ID) obtained in different organs derived from the PET data.
1 day
Yes
Donald Podoloff, MD, BA
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2009-0157
NCT01320787
December 2013
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |