Intra-arterial Y-90 TheraSpheres for Hepatic Metastases From Solid Tumors

Exclusion Criteria

• •At risk of hepatic or renal failure, as indicated by any of the following pre-treatment laboratory and clinical findings within 28 days of treatment:
• •* Serum creatinine \> 2.0 mg/dL, unless on dialysis
• •* Serum total bilirubin ≥ 2.0 mg/dL
• •* Albumin \< 2.0 g/dL
• •* Any history of hepatic encephalopathy
• •Contraindications to angiography and selective visceral catheterization that may include, but are not limited to, the following:
• •* Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g., closure device)
• •* Severe peripheral vascular disease precluding catheterization
• •* History of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically.
• •Severe liver dysfunction or presentation of pulmonary insufficiency or a clinically evident history of chronic obstructive pulmonary disease
• •Cirrhosis or portal hypertension
• •Previous external beam radiation treatment to the liver
• •Any intervention for, or compromise of the Ampulla of Vater
• •Clinically evident ascites. (Note: A radiographic finding of trace ascites on imaging is acceptable).
• •Any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before the first treatment with TheraSphere (if the investigator determines that the continuing complication will compromise the safety of the patient following treatment with TheraSphere).
• •In the judgment of the physician, significant life-threatening extrahepatic disease
• •Concurrent enrollment in another clinical study
• •Evidence on technetium-99m macroaggregated albumin (99mTc-MAA) scan that demonstrates lung shunting with a potential absorbed dose of radiation to the lungs \>30 Gy. The 30 Gy limit is a cumulative limit over all infusions of TheraSphere.
• •Evidence on technetium-99m macroaggregated albumin (99mTc-MAA) scan that demonstrates a potential for the deposition of microspheres to the gastrointestinal tract that cannot be corrected by placement of the catheter distal to collateral vessels or using standard angiographic techniques, such as coil embolization.
• •A positive serum pregnancy test in women of childbearing potential
• •In the Investigator's judgment, any co-morbid disease or condition or event (e.g., recent myocardial infarction) that would place the patient at undue risk, and that would preclude safe use of TheraSphere