A Phase I Study of 18F-Fluoro-PEG6-IPQA as a PET Imaging Agent for Active/Mutant EGFR Expression in Tumors
18F-PEG6-IPQA is a solution that is designed to be attracted to tumor cells. The imaging
solution has a small dose of radiation added to it, which may help doctors see the cancer
cells better during imaging scans. This is the first study using 18F-PEG6-IPQA in humans.
Study Imaging:
If you are found to be eligible to take part in this study, you will visit the clinic on Day
1 for the injection of the study solution and PET scans. This imaging study will be
performed at FDA-cleared PET-CT scanners at MD Anderson sites, including at the Center for
Advanced Biomedical Imaging Research (CABIR).
For up to 6 hours before the PET scans and computed tomography (CT) scans, you must not eat
or drink anything except water. This is called fasting.
A small tube will be placed in your arm and you will receive an injection of 18F-PEG6-IPQA.
After the injection, scanning will begin immediately. You will have 3 PET scanning
sessions with a PET/CT scanner. Before each PET scan, you will have a CT scan to make sure
you are in the right position for the PET scans. Each PET scan may last up to 1 hour. Each
positioning CT scan should take about 5 minutes. You will have a 10 minute "rest period"
between each PET scan.
Study Visits:
On Day 1:
- Before the imaging solution is injected, your vital signs and an ECG rhythm strip will
be collected. The study staff will insert an intravenous (IV) needle and line into
each of your arms.
- Right after the injection of the study drug, blood (about 2 tablespoons total) will be
drawn for pharmacokinetic (PK) testing from one of the existing IV lines. PK testing
measures the amount of study solution in the body at different time points. Blood will
be drawn at 1, 3, 8, 16, 30, 45, 60, 90, and 150 minutes after the injection of
18F-PEG6-IPQA for a total of 9 draws.
- About 30 minutes after the injection, your vital signs will be measured and the
injection site will be checked.
- Urine will be collected during the 10 minute rest periods in between scans or at the
completion of the 3-hour scanning period.
- After the scans are completed (about 3 hours after the injection) your vital signs and
injections site will be checked again, and you will have an ECG rhythm strip taken.
Blood (about 2 tablespoons) and urine will also be collected for routine tests.
On Days 2 and 7:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- Your vital signs and the injection site will be checked
- You will be asked about any side effects you may be having since the injection.
End-of-Study Visit:
The end-of-study visit will be about 14 days after the injection of 18F-PEG6-IPQA and
imaging scans. The following tests and procedures will be performed:
- Blood (about 2-3 tablespoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs.
- The injection site will be checked.
- You will have an ECG.
Length of Study:
You will be in this study for about 14 days. You will be taken off study early if
intolerable side effects occur.
This is an investigational study. 18F-PEG6-IPQA is not FDA-approved or commercially
available for use in imaging scans. Its use in this study is investigational.
The scans performed with 18F-PEG6-IPQA are also considered investigational and will not be
used for planning any of your future cancer treatment.
Up to 15 patients will take part in this study. All participants will be enrolled at M. D.
Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Optimum dosimetry of 18F-PEG6-IPQA sodium injection based on critical organ safety
Safety endpoints summarized by counts and percents by tumor type: Occurrence of one or more changes from baseline, at each post-treatment time point, greater than 40% and 80% of span of the normal limits; or, Occurrence of post-treatment values that are changes greater than 80% of the span of the normal limits.
Safety measurements performed from administration of injection until 2 weeks after administration.
Yes
Donald Podoloff, MD,BA
Principal Investigator
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2009-0832
NCT01320059
February 2012
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |