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

September 28, 2022 updated by: Kenneth J Kolbeck MD PhD, OHSU Knight Cancer Institute

A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

339

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Treatment
yttrium 90 (TheraSphere) administration
Device: Yttrium 90 (TheraSphere)
Y-90 embedded glass microspheres
Other Names:
  • TheraSphere
  • Y-90
  • Yttrium - 90

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 weeks, 1 month and then every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University
Boston Scientific Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (ACTUAL)

April 28, 2021

Study Completion (ACTUAL)

April 28, 2021

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (ESTIMATE)

August 25, 2008

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00002377
  • HDE 2377 (OTHER: Oregon Health & Science University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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