HepatoCellular Carcinoma, Liver Cancer, Liver Neoplasms
Conditions
Keywords
Humanitarian Device Exemption, Liver Disease, HDE #980006
Brief summary
This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.
Interventions
DEVICETheraSphere Treatment
TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.
Sponsors
Biocompatibles UK Ltd
BTG International Inc.
H. Lee Moffitt Cancer Center and Research Institute
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
United States
Outcome results
None listed