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

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ClinicalTrials.gov Identifier: NCT01290523
Recruitment Status : Terminated (Off study clinical use of Y90 glass microspheres (TheraSphere))
First Posted : February 7, 2011
Results First Posted : August 25, 2015
Last Update Posted : August 25, 2015
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatocellular Carcinoma Device: Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2010
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
Drug Information available for: Yttrium
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 6 months ]
    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 :
  1. Radiographic Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290523

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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01290523     History of Changes
Other Study ID Numbers: UCSF-SIRT-HCC
First Posted: February 7, 2011    Key Record Dates
Results First Posted: August 25, 2015
Last Update Posted: August 25, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors