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A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®

NCT00877136 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2021-04-06

No results posted yet for this study

Summary

This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives:

1. Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates.
2. Evaluate patient experience and toxicities associated with TheraSphere® treatment.
3. Measure tumor response rates

Conditions

Interventions

DEVICE

TheraSphere®

TheraSphere® consists of insoluble glass microspheres where yttrium-90 is an integral constituent of the glass. TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. This artery provides the main blood supply to the tumor in the liver. TheraSphere® being unable to traverse the tumor vasculature is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.

Sponsors & Collaborators

  • St. Joseph Hospital of Orange

    lead OTHER

Principal Investigators

  • Lawrence Wagman, M.D., F.A.C.S. · St. Joseph Hospital of Orange

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2015-02-28
Completion
2021-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00877136 on ClinicalTrials.gov