Therasphere for Unresectable Primary or Secondary Liver Neoplasia

A Humanitarian Device Exemption (HDE) Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia - HDE #980006

This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.

Inclusion Criteria:

• Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.
• Potential candidates are those diagnosed with primary or secondary liver neoplasia. 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 and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing Hepatocellular Carcinoma (HCC).
• Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2
• Life expectancy ≥ 3 months
• > 4 weeks since prior radiation, surgery or chemotherapy
• Able to comprehend and provide consent in accordance with institutional and federal guidelines

Exclusion Criteria:

• Any other liver therapy planned for cancer treatment
• Uncorrectable flow to the gastrointestinal tract
• Estimated radiation doses to the lungs greater than 30 Gy in a single administration or 50 Gy in multiple administrations
• Significant extrahepatic disease representing imminent life-threatening outcome
• Pregnancy