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

Study Description

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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 Design

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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
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
University of California San Francisco
San Francisco, California, United States, 94143

Sponsors and Collaborators

University of California, San Francisco

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Results First Posted:	August 25, 2015
Last Update Posted:	August 25, 2015
Last Verified:	July 2015

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Methamphetamine; Central Nervous System Stimulants	Physiological Effects of Drugs; Sympathomimetics; 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