Trial Information
A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms.
Outcome Time Frame:
2 weeks, 1 month and then every 3 months
Safety Issue:
Yes
Principal Investigator
John A Kaufman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dotter Interventional Institute Oregon Health & Science University
Authority:
United States: Institutional Review Board
Study ID:
HDE 2377
NCT ID:
NCT00740753
Start Date:
August 2004
Completion Date:
January 2020
Related Keywords:
- Liver Cancer
- Hepatoma
- liver tumor
- cancer
- hepatoma
- yttrium
- Liver Neoplasms
- Carcinoma, Hepatocellular