Expired Study
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San Francisco, California 94143


Purpose:

This is a prospective pilot study that will document the clinical experience of 30 patients with unresectable hepatocellular carcinoma undergoing liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere®).


Criteria:

Inclusion Criteria: - Diagnosis of hepatocellular carcinoma with liver-dominant disease. Diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria. - The cancer is unresectable. - All patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after TheraSphere treatment. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. - Age 18 years or older. - Able to understand informed consent. Exclusion Criteria: - Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either: - single TheraSphere administration; or - cumulative delivery of radiation to the lungs greater than 50 Gy over multiple treatments. - Evidence of any detectable Tc-99m macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow. - Previous radiation therapy to the lungs and/or to the upper abdomen - Pregnancy - Symptomatic lung disease. - Significant extrahepatic disease representing an imminent life-threatening outcome. - Active uncontrolled infection - Any pre-treatment laboratory findings within 30 days of treatment demonstrating: - Aspartate or alanine aminotransferase level greater than 5 times upper normal limit. - Serum bilirubin greater than 2 mg/dl - Infiltrative tumor on imaging - Tumor volume greater than 70% of liver volume - Tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dL


NCT ID:

NCT01290523


Primary Contact:

Principal Investigator
Nicholas Fidelman, MD
University of California, San Francisco


Backup Contact:

N/A


Location Contact:

San Francisco, California 94143
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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