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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00740753
First Posted: August 25, 2008
Last Update Posted: November 9, 2017
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.
Information provided by (Responsible Party):
John A. Kaufman, Oregon Health and Science University
  Purpose
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 Intervention
Liver Cancer Hepatoma Device: Yttrium 90 (TheraSphere)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by John A. Kaufman, Oregon Health and Science University:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 400
Study Start Date: August 2004
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
yttrium 90 (TheraSphere) administration
Device: Yttrium 90 (TheraSphere)
Y-90 embedded glass microspheres
Other Names:
  • Yttrium - 90
  • Y-90
  • TheraSphere

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Oregon Health and Science University
Investigators
Principal Investigator: John A Kaufman, MD Dotter Interventional Institute Oregon Health & Science University
  More Information

Responsible Party: John A. Kaufman, Director Dotter Interventional Unit / Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00740753     History of Changes
Other Study ID Numbers: HDE 2377
First Submitted: August 22, 2008
First Posted: August 25, 2008
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by John A. Kaufman, Oregon Health and Science University:
liver tumor
cancer
hepatoma
yttrium

Additional relevant MeSH terms:
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