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

Sponsored by:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00740753

Purpose

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.

Condition	Intervention
Liver Cancer Hepatoma	Device: Yttrium 90 (TheraSphere)

MedlinePlus related topics: Cancer Liver Cancer Methamphetamine

Drug Information available for: Amphetamine Methamphetamine TheraSphere

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	August 2004

Intervention Details:

Y-90 embedded glass microspheres

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740753

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:

John A Kaufman, MD

Dotter Interventional Institute Oregon Health & Science University

More Information

Responsible Party:	Dotter Interventional Institute, Oregon Health and Science University ( John A. Kaufman MD )
Study ID Numbers:	HDE 2377
Study First Received:	August 22, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00740753
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

liver tumor
cancer
hepatoma
yttrium

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Carcinoma
Liver Neoplasms
Methamphetamine

Digestive System Diseases
Gastrointestinal Neoplasms
Amphetamine
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009