TheraSphere HUD For Treatment of Unresectable HCC

Inclusion Criteria:

- Patients over 18 years of age, of any race or sex, who have histologic proof of
primary cancer to the liver, who are able to give informed consent, will be eligible.

- Patients must have an ECOG Performance Status score of greater than or equal to 2,
with a life expectancy of > 3 months, non-pregnant with an acceptable contraception
in premenopausal women.

- The histopathology confirmation criterion may be waived in patients with a
radiographically identifiable liver mass, known laboratory or clinical risk factors
for cancer or elevated tumor markers such as AFP (clinical diagnosis).

- Participation in the TheraSphere Registry.

Exclusion Criteria:

- Contraindications to angiography and selective visceral catheterization

- Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of
radiation to the lungs

- Evidence of any detectable Tc-99 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

- Pregnancy

- Refusal to participate in the TheraSphere Registry