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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

Tracking Information
First Submitted Date  ICMJE August 22, 2008
First Posted Date  ICMJE August 25, 2008
Last Update Posted Date September 30, 2022
Study Start Date  ICMJE August 2004
Actual Primary Completion Date April 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option
Official Title  ICMJE A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Cancer
  • Hepatoma
Intervention  ICMJE Device: Yttrium 90 (TheraSphere)
Y-90 embedded glass microspheres
Other Names:
  • Yttrium - 90
  • Y-90
  • TheraSphere
Study Arms  ICMJE Treatment
yttrium 90 (TheraSphere) administration
Intervention: Device: Yttrium 90 (TheraSphere)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2021)
339
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2008)
250
Actual Study Completion Date  ICMJE April 28, 2021
Actual Primary Completion Date April 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00740753
Other Study ID Numbers  ICMJE IRB00002377
HDE 2377 ( Other Identifier: Oregon Health & Science University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kenneth J Kolbeck MD PhD, OHSU Knight Cancer Institute
Original Responsible Party John A. Kaufman MD, Dotter Interventional Institute, Oregon Health and Science University
Current Study Sponsor  ICMJE OHSU Knight Cancer Institute
Original Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE
  • Oregon Health and Science University
  • Boston Scientific Corporation
Investigators  ICMJE
Principal Investigator: Kenneth Kolbeck, MD, PhD OHSU Knight Cancer Institute
PRS Account OHSU Knight Cancer Institute
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP