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Brief Title: A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®
Official Title: A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®
Study ID: NCT00877136
Brief Summary: This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives: 1. Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates. 2. Evaluate patient experience and toxicities associated with TheraSphere® treatment. 3. Measure tumor response rates
Detailed Description: The purpose of this protocol is to provide supervised access at this institution to TheraSphere® treatment for a heterogeneous population of patients with unresectable primary liver tumors, with the liver being the only dominant site of disease. Based on experience gained in previous studies and well-established interventional radiology techniques, this protocol allows multiple treatments with TheraSphere® that may be delivered on an inpatient or out patient basis. Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 - 90 days apart. The investigator, working with co-investigators in radiation oncology, interventional radiology and nuclear medicine, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy, and the desired goal of treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Center for Cancer Prevention & Treatment at St. Joseph Hospital of Orange, Orange, California, United States
Name: Lawrence Wagman, M.D., F.A.C.S.
Affiliation: St. Joseph Hospital of Orange
Role: PRINCIPAL_INVESTIGATOR