Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option

NCT ID: NCT00740753

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2021-04-28

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.

Conditions

Liver Cancer; Hepatoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

yttrium 90 (TheraSphere) administration

Group Type: OTHER

Yttrium 90 (TheraSphere)

Intervention Type: DEVICE

Y-90 embedded glass microspheres

Interventions

Yttrium 90 (TheraSphere)

Y-90 embedded glass microspheres

Intervention Type: DEVICE

Other Intervention Names

Yttrium - 90; Y-90; TheraSphere

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Kenneth J Kolbeck MD PhD

Associate Professor, Charles T. Dotter Department of Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Kolbeck, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Other Identifiers

HDE 2377

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00002377

Identifier Type: -

Identifier Source: org_study_id