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NCT00740753 Clinical Trial

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

Liver Cancer Clinical Trial

— Y-90HDE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00740753
Other study ID # IRB00002377
Secondary ID HDE 2377
Status Completed
Phase N/A
First received
Last updated
Start date August 2004
Est. completion date April 28, 2021

Study information
Verified date September 2022
Source OHSU Knight Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 339
Est. completion date April 28, 2021
Est. primary completion date April 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Yttrium 90 (TheraSphere)
Y-90 embedded glass microspheres

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
OHSU Knight Cancer Institute Boston Scientific Corporation, Oregon Health and Science University

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms. Tumors will decrease in size 2 weeks, 1 month and then every 3 months
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