A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
OBJECTIVES:
- Provide supervised access to treatment with yttrium Y 90 glass microspheres
(TheraSphere®) to eligible patients with cancer of the liver who are not candidates for
surgical resection.
- Evaluate patient experience and toxicities associated with yttrium Y 90 glass
microspheres (TheraSphere®) treatment.
OUTLINE: This is a humanitarian device exemption use study.
Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through
a percutaneously placed catheter into the hepatic artery. Patients may receive additional
treatment 4-12 weeks after initial treatment at the discretion of the study physician.
After completion of study treatment, patients are followed at 2 weeks, 30 days, and then
once a year for approximately 2 years.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Proportion of patients completing scheduled treatment plan
At point that patient discontinues treatment for whatever reason.
No
Riad Salem, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
NU 1365-001
NCT00530010
December 2004
January 2016
Name | Location |
---|---|
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |