Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Hepatocellular Carcinoma: A Pilot Study

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