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

This study has been terminated.
(Off study clinical use of Y90 glass microspheres (TheraSphere))
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: February 1, 2011
Last updated: July 28, 2015
Last verified: July 2015
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®).

Condition Intervention Phase
Hepatocellular Carcinoma
Device: Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Profile Assessment of TheraSphere® Yttrium-90 Glass Microspheres Used for Treatment of Hepatocellular Carcinoma: A Pilot Study

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Adverse events of treatment with TheraSphere Yttrium-90 glass microspheres will be assessed within 6 months of treatment administration. Anticipated adverse events may include liver dysfunction, gastrointestinal ulcer formation, cholecystitis, pneumonitis, fatigue, nausea/vomiting, abdominal pain

Secondary Outcome Measures:
  • Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: May 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yttrium-90 liver radioembolization
Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)
Device: Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)
Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01290523

United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco Identifier: NCT01290523     History of Changes
Other Study ID Numbers: UCSF-SIRT-HCC 
Study First Received: February 1, 2011
Results First Received: July 28, 2015
Last Updated: July 28, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial processed this record on May 26, 2016