A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
The objectives of this study are to provide supervised access to treatment with TheraSphere
to eligible patients with Hepatocellular Carcinoma of the liver who are not surgical
resection candidates and to evaluate patient experience, toxicities and overall survival
associated with TheraSphere treatment.
This is an observational treatment use protocol that will provide IRB oversight and
documentation of the clinical experience of patients undergoing treatment for liver
carcinoma using TheraSphere. Participation involves no investigational or research
procedures. Patients will be followed for treatment-related adverse experiences and will be
monitored in accordance with institutional practices. Approximately 60 patients will be
enrolled in a treatment protocol and the number may be expanded following completion of the
first cohort. The total number of patients to be treated will be determined based on
clinical experience and patient outcomes. There are no control subjects in this treatment
protocol.
The duration of the protocol will depend on patient experience with this treatment. An
initial one year approval is sought at this time. Patient experience will be evaluated
continuously and if the clinicians find that the treatment provides benefits to patients,
renewal of the approval will be sought after the first 12 months.
Observational
Observational Model: Case-Only
Progression of liver cancer
6 months
No
David A Iannitti, MD
Principal Investigator
Carolinas Medical Center
United States: Institutional Review Board
HDE# 980006
NCT00605150
January 2008
January 2009
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