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

Primary Purpose

Liver Cancer, Hepatoma

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Yttrium 90 (TheraSphere)

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring liver tumor, cancer, hepatoma, yttrium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

yttrium 90 (TheraSphere) administration

Outcomes

Primary Outcome Measures

Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms.

Tumors will decrease in size

Secondary Outcome Measures

Full Information

NCT ID

NCT00740753

First Posted

August 22, 2008

Last Updated

September 28, 2022

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University, Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00740753

Brief Title

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

Acronym

Y-90HDE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

April 28, 2021 (Actual)

Study Completion Date

April 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University, Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer, Hepatoma

Keywords

liver tumor, cancer, hepatoma, yttrium

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

339 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Other

Arm Description

yttrium 90 (TheraSphere) administration

Intervention Type

Device

Intervention Name(s)

Yttrium 90 (TheraSphere)

Other Intervention Name(s)

Yttrium - 90, Y-90, TheraSphere

Intervention Description

Y-90 embedded glass microspheres

Primary Outcome Measure Information:

Title

Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms.

Description

Tumors will decrease in size

Time Frame

2 weeks, 1 month and then every 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth Kolbeck, MD, PhD

Organizational Affiliation

OHSU Knight Cancer Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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