NCT00740753

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
339

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2021

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

16.8 years

First QC Date

August 22, 2008

Last Update Submit

September 28, 2022

Conditions

Liver CancerHepatoma

Keywords

liver tumorcancerhepatomayttrium

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Treatment

OTHER

yttrium 90 (TheraSphere) administration

Device: Yttrium 90 (TheraSphere)

Interventions

Yttrium 90 (TheraSphere)DEVICE

Y-90 embedded glass microspheres

Also known as: Yttrium - 90, Y-90, TheraSphere
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of HCC
  • Cancer is unresectable
  • ECOG Score 0-2
  • Age of 18 yrs or over
  • Able to give consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, HepatocellularNeoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Kenneth Kolbeck, MD, PhD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Charles T. Dotter Department of Interventional Radiology

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

August 1, 2004

Primary Completion

April 28, 2021

Study Completion

April 28, 2021

Last Updated

September 30, 2022

Record last verified: 2022-09