Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option (Y-90HDE)
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
339 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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