TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis

A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis

Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.

Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90.

Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.

Inclusion Criteria:

• 18 yrs of age or older

• Diagnosis of Hepatocellular Carcinoma

• Portal Vein Thrombosis

• ECOG performance < 2

  ->4 weeks since prior radiation, surgery or chemotherapy.

• Life expectancy > 3 months

• Able to provide written informed consent process in accordance with institutional review boards guidelines.

Exclusion Criteria:

• Contraindications to angiography and selective visceral catheterization.
• Evidence of blood flow to the lung from the liver greater than 16.5 mCi
• Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow.
• Significant extrahepatic disease.
• Severe liver disfunction of pulmonary insufficiency.
• Active uncontrolled infection.
• Significant underlying medical or psychiatric illness.
• Pregnancy. Patients will be excluded if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.