A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006

Inclusion Criteria:

- Confirmed diagnosis of primary or metastatic intrahepatic carcinoma

- The cancer must be unresectable with limited established treatment options

- ECOG Performance Status Score 0-2

- Age 19 years or older

- Able to comprehend and provide written informed consent

Exclusion Criteria:

- Any pre-treatment laboratory findings within 15 days of treatment demonstrating:

- Absolute granulocyte count ≤ 1,500/ul

- Platelet count ≤ 75,000/ul

- Serum creatinine > 2.0 mg/dl

- Serum bilirubin ≥ 2.0 mg/dl

- Any of the following contraindications to angiography and selective visceral
catheterization:

- History of severe allergy or intolerance to any contrast media, narcotics, sedatives,
or atropine

- Bleeding, diathesis, not correctable by usual forms of therapy

- Severe peripheral vascular disease that would preclude catheterization

- Substantial venous shunt away from the liver

- Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of
radiation to the lungs on either 1) first Therasphere® administration; or 2)
cumulative delivery of radiation to the lungs over multiple treatments

- Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of
established angiographic techniques to stop such flow

- Significant extrahepatic disease representing an imminent life- threatening situation
outcome

- Severe liver dysfunction or pulmonary insufficiency

- Active uncontrolled infection

- Significant underlying medical or psychiatric illness

- Pregnant women may not participate