This clinical investigation involves the use of an approved medical device (SIR-Spheres®) for a new purpose in patients with certain types of liver cancer. The goal is to determine whether this treatment can help patients qualify for or maintain eligibility for a liver transplant. Participation is completely voluntary and will not affect your standard medical care. The main risks involve possible side effects related to the use of radiation in the liver, such as fatigue, abdominal pain, nausea, or changes in liver function. You may or may not benefit personally from participating in this study, but the results may help improve future treatment for others.
Your doctor is inviting you to take part in this clinical investigation because you have been diagnosed with liver cancer. Your doctors will have decided that treatments designed to remove or destroy cancer completely, such as surgery or heat treatment, are not suitable for you.
This clinical investigation is focused on testing how well selective internal radiation therapy (SIRT) using SIR-Spheres® Y-90 resin microspheres ("SIR-Spheres") work, its potential benefits, its safety, and finding out if there are any bad effects when it's used like it's supposed to be used. For more information, please see the section on the purpose of the clinical investigation.
This Patient Informed Consent Form (PIC) tells you about the clinical investigation. It explains the tests and treatments involved and how your information will be used. Knowing what is involved will help you decide if you want to take part in the clinical investigation.
Willing, able, and mentally competent to provide written informed consent
Age 18 years or older at the time of informed consent
All tumors must be measurable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) according to localized mRECIST
Diagnosis of HCC with Liver Imaging Reporting and Data System (LIRADS) 5 or by histology that is amenable to treatment with Y-90 radioembolization by radiation segmentectomy
Eligible for curative treatment by resection or not considered optimal candidates for curative ablation, in the opinion of the investigator, based on tumor location, multifocality, underlying liver disease, anticipated risk of recurrence, or institutional practice patterns.
Prior systemic anti-cancer therapy (including immunotherapy and/or targeted therapy), radiotherapy or use of other investigational agents for the treatment of HCC
Intrahepatic arteriovenous shunting (arteriovenous shunting resulting from a biopsy is allowed but must be embolized during the pre-treatment mapping procedure)
History of biliary-enteric anastomosis (e.g., hepaticojejunostomy) or active biliary infection (e.g., ongoing cholangitis) at the time of screening. Subjects with prior biliary intervention (e.g., Endoscopic Retrograde Cholangiopancreatography (ERCP), sphincterotomy, biliary stent placement) or suspected compromise of the Ampulla of Vater may be enrolled at the Investigator's discretion provided there is no evidence of active biliary infection and prophylactic antibiotic coverage is administered per institutional standard of care before and after Y-90 radioembolization.