TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Surgical resection of the affected portion of the liver offers the best chance for
disease-free survival in patients with primary liver cancer (hepatocellular carcinoma
(HCC)). Unfortunately, most of these patients present with disease that is not amenable to
surgery (multifocal disease) or have other medical contraindications to surgery (limited
hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15% of HCC
patients are suitable surgical candidates. The objective of treatment with TheraSphere is to
selectively administer a potentially lethal dose of radioactive material to cancerous tissue
in the liver of patients with HCC. This type of regional therapy may have several advantages
over systemically administered treatments and may also be of value as a 'bridging' treatment
for HCC patients awaiting a donor organ for liver transplantation.

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