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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00740753
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : September 30, 2022
Sponsor:
Collaborators:
Oregon Health and Science University
Boston Scientific Corporation
Information provided by (Responsible Party):
Kenneth J Kolbeck MD PhD, OHSU Knight Cancer Institute

Study Description
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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
Liver Cancer Hepatoma Device: Yttrium 90 (TheraSphere) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : August 2004
Actual Primary Completion Date : April 28, 2021
Actual Study Completion Date : April 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Yttrium

Arms and Interventions
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Arm Intervention/treatment
Treatment
yttrium 90 (TheraSphere) administration
 Device: Yttrium 90 (TheraSphere)
Y-90 embedded glass microspheres
Other Names:
  • Yttrium - 90
  • Y-90
  • TheraSphere


Outcome Measures
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Primary Outcome Measures :
  1. Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms. [ Time Frame: 2 weeks, 1 month and then every 3 months ]
    Tumors will decrease in size


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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740753


Sponsors and Collaborators
OHSU Knight Cancer Institute
Oregon Health and Science University
Boston Scientific Corporation
Investigators
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Principal Investigator: Kenneth Kolbeck, MD, PhD OHSU Knight Cancer Institute
More Information
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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 ( Other Identifier: Oregon Health & Science University )
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kenneth J Kolbeck MD PhD, OHSU Knight Cancer Institute:
liver tumor
cancer
hepatoma
yttrium
Additional relevant MeSH terms:
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Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type