TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma
The purpose of this protocol is to provide TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. The effect on the tumor and any side effects of TheraSphere treatment will be examined. This study will provide supervised and limited access to TheraSphere treatment at University California Irvine Medical Center.
TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. When Y-90 is incorporated into very tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels supplying the liver. This allows a large dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. The radiation from TheraSphere is contained within the body and becomes minimally active within 7 days after treatment due to physical decay. The glass beads remain in the body, but do not cause any health problems. TheraSphere has been approved for use in the treatment of liver cancer in the United States by the Food and Drug Administration on a limited basis.
Primary Liver Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Humanitarian Device Exemption Use Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma|
- 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. [ Time Frame: Every 3-6 months ] [ Designated as safety issue: No ]
- Evaluate for side effects [ Time Frame: Every 1-2 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
No Intervention: TheraSphere® treatment
TheraSphere® treatment will be performed in the outpatient setting.
Within two weeks (14 days) of initial treatment, a catheter will be placed and liver angiography will be performed to confirm eligibility, followed by a Technetium-99 Macroaggregated Albumin (Tc-99m MAA) study. If either study indicates an uncorrectable risk of flow to the gastrointestinal organs or risk of shunting to the lungs, TheraSphere® treatment will not be administered. In this event, the patient will receive alternative treatment (chemoembolization) or no treatment, as previously defined in the treatment plan. If the patient remains eligible, TheraSphere® will be administered within two weeks.
All patients will be evaluated at 30 days post-treatment to assess clinical experience and adverse experiences. Subsequently, patient status will be followed via communication with the referring oncologist to determine disease status and survival. Survival surveillance will continue up to 24 months.
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.
|Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center||(877) 827-8839||UCstudy@uci.edu|
|United States, California|
|Chao Family Comprehensive Cancer Center||Recruiting|
|Orange, California, United States, 92868|
|Principal Investigator: David K Imagawa, MD, PhD|
|Principal Investigator:||David K Imagawa, MD, PhD||University of California, Irvine|