A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
- 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
- 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 Model: Cohort, Time Perspective: Prospective
Proportion of patients completing scheduled treatment plan
At point that patient discontinues treatment for whatever reason.
Riad Salem, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|