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