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Y-90HDE: Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option

Sponsor
OHSU Knight Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00740753
Collaborator
Oregon Health and Science University (Other), Boston Scientific Corporation (Industry)
339
Enrollment
1
Arm
200.9
Duration (Months)

Study Details

Study Description

Brief Summary

Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. The radioactive beads are placed directly near or into the liver tumor with the intention of destroying the tumor cells.

Condition or Disease Intervention/Treatment Phase
  • Device: Yttrium 90 (TheraSphere)
 N/A

Detailed Description

Patients receive Y-90 (yttrium) glass microspheres via percutaneous hepatic arterial infusion. Patients amy be retreated between 30-90 days after initial infusion. After completion of therapy, patients are followed for 30 days and then every 3 months for up to 2 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
339 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Apr 28, 2021
Actual Study Completion Date :
Apr 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Treatment

yttrium 90 (TheraSphere) administration

Device: Yttrium 90 (TheraSphere)
Y-90 embedded glass microspheres
Other Names:
  • Yttrium - 90
  • Y-90
  • TheraSphere

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms. [2 weeks, 1 month and then every 3 months]

      Tumors will decrease in size

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Confirmed diagnosis of HCC

    • Cancer is unresectable

    • ECOG Score 0-2

    • Age of 18 yrs or over

    • Able to give consent

    Exclusion Criteria:

    • Contraindication to angiography and selective visceral catheterization

    • Portal hypertension with portal venous shunt away from the liver

    • Evidence of potential delivery of > 16.5 mCi of radiation to the lungs

    • Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow

    • Significant extrahepatic disease representing an imminent life-threatening outcome

    • Severe liver dysfunction or pulmonary insufficiency

    • Active uncontrolled infection

    • Significant underlying medical or psychiatric illness

    • Pregnancy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • OHSU Knight Cancer Institute
    • Oregon Health and Science University
    • Boston Scientific Corporation

    Investigators

    • Principal Investigator: Kenneth Kolbeck, MD, PhD, OHSU Knight Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kenneth J Kolbeck MD PhD, Associate Professor, Charles T. Dotter Department of Interventional Radiology, OHSU Knight Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT00740753
    Other Study ID Numbers:
    • IRB00002377
    • HDE 2377
    First Posted:
    Aug 25, 2008
    Last Update Posted:
    May 18, 2021
    Last Verified:
    May 1, 2021
    Keywords provided by Kenneth J Kolbeck MD PhD, Associate Professor, Charles T. Dotter Department of Interventional Radiology, OHSU Knight Cancer Institute
    liver tumor
    cancer
    hepatoma
    yttrium
    Additional relevant MeSH terms:
    Liver Neoplasms
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of May 18, 2021