Text Size

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:
Information provided by (Responsible Party):
John A. Kaufman, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00740753
First received: August 22, 2008
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  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: 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:

Drug Information available for: Yttrium
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 22, 2008
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013