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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))
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01290523
First received: February 1, 2011
Last updated: July 28, 2015
Last verified: July 2015
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Purpose
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: | 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 ]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 ]
| 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
|
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290523
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290523
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
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov 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 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017