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TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma

NCT00906984 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2024-01-08

No results posted yet for this study

Summary

The purpose of this protocol is to provide TheraSphere treatment for patients with liver cancer who cannot be treated by surgery. The effect on the tumor and any side effects of TheraSphere treatment will be examined. This study will provide supervised and limited access to TheraSphere treatment at University California Irvine Medical Center.

TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. When Y-90 is incorporated into very tiny glass beads (TheraSphere), it can be injected to the liver through blood vessels supplying the liver. This allows a large dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue. The radiation from TheraSphere is contained within the body and becomes minimally active within 7 days after treatment due to physical decay. The glass beads remain in the body, but do not cause any health problems. TheraSphere has been approved for use in the treatment of liver cancer in the United States by the Food and Drug Administration on a limited basis.

Conditions

Interventions

DEVICE

TheraSphere

Given IV

Sponsors & Collaborators

  • BTG International Inc.

    collaborator OTHER

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Nadine Abi-Jaoudeh, MD · University of California, Irvine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00906984 on ClinicalTrials.gov