Yttrium-90 Radioembolization With Glass Microspheres (TheraSphere) for Patients With Hepatocellular Carcinoma

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

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®).

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