Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option
Not Applicable
Completed
- Conditions
- HepatomaLiver Cancer
- Interventions
- Device: Yttrium 90 (TheraSphere)
- Registration Number
- NCT00740753
- Lead Sponsor
- OHSU Knight Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 339
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Yttrium 90 (TheraSphere) yttrium 90 (TheraSphere) administration
- Primary Outcome Measures
Name Time Method Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms. 2 weeks, 1 month and then every 3 months Tumors will decrease in size
- Secondary Outcome Measures
Name Time Method