A Phase II, Open Label, Non-randomized, Multi-center, Pilot, Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
The aim of this pilot study is to examine the utility of a new molecular imaging tracer,
[F-18]RGD-K5 to monitor treatment responses in patients scheduled to undergo treatment with
Avastin® (Bevacizumab) plus standard chemotherapy. The changes of [F-18]RGD-K5 PET/CT image
scans between before treatment and after both mid-treatment cycles of Avastin® (Bevacizumab)
will be evaluated. The hypothesis for this study is that changes in the uptake of
[F-18]RGD-K5 PET in tumors may reflect changes in the level of integrin expression and/or
angiogenesis. This pilot study will help to define if changes in uptake of [F-18]RGD-K5 are
an early indicator of treatment efficacy to Avastin®.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed.
(5) visits over a period of approximately 5 cycles of Avastin
No
Edward Aten, MD
Study Director
President, Certus International
United States: Food and Drug Administration
K5-101
NCT00988936
September 2009
May 2012
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Mount Sinai School of Medicine | New York, New York 10029 |
Beth Israel Medical Center | New York, New York 10003 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
University of California, Irvine | Orange, California 92868 |
UMDNJ | Newark, New Jersey 07107 |
Eastern Regional Medical Center | Philadelphia, Pennsylvania |
Hospital of University of Pennsylvania | Philadelphia, Pennsylvania 19104 |