A Humanitarian Device Exemption Use Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
This protocol provides TheraSphere treatment for patients with liver cancer who cannot be
treated by surgery. Patients with hepatocellular carcinoma will be evaluated for eligibility
for this treatment with the following: physical examination, medical history, blood tests
requiring approximately 2 tablespoons of blood, EKG, CT or MR of chest to examine lungs, CT
or magnetic resonance (MR) of abdomen to evaluate liver, stomach and intestines, and bone
scan to rule out spread of disease to bones. If eligible on initial screening, patients will
proceed to a second stage of screening, including an hepatic angiogram to confirm treatment
can be provided safely and to highlight the blood vessels supplying the liver, and a nuclear
medicine study (Tc-99m MAA scan) to display the blood flow to the lungs, stomach and
intestines.
When it is determined treatment can be delivered safely, patients will receive TheraSphere
via the hepatic artery through blood vessels supplying the liver on an outpatient basis.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The protocol allows for prospective collection of data. There is no randomization to an alternative form of therapy. However, we measure tumor response after treatment based on CT scans and tumor markers.
Every 3-6 months
No
David K Imagawa, MD, PhD
Principal Investigator
University of California, Irvine
United States: Food and Drug Administration
UCI 01-61
NCT00906984
May 2002
December 2013
Name | Location |
---|---|
Chao Family Comprehensive Cancer Center | Orange, California 92868 |