This study is a non-interventional, observational, prospective, and global participant data registry. The study will collect effectiveness and safety data from approximately 1000 participants with liver cancers treated with TheraSphere® in a real-life setting from multiple centers globally. The absorbed dose to tumor and normal tissue will be calculated using the Simplicit90Y™ software in the subgroup of hepatocellular carcinoma (HCC) participants.
This study is a non-interventional, observational, prospective and global participant data registry. Approximately 1000 participants with liver cancers who are treated with TheraSphere® will be enrolled. Data regarding participant and treatment characteristics (TheraSphere® and other anti-cancer treatments) will be collected within a 12-month period post TheraSphere® administration to: * Assess treatment effectiveness and safety in a real-life administration setting * Identify prognostic and predictive factors for liver cancer participants receiving TheraSphere® treatment Data for dosimetry determination will be collected on approximately 300 HCC participants to assess: * Technetium-99m Macroaggregated albumin (99mTc-MAA) normal tissue and tumor Absorbed Dose using pre-procedural Single Proton Emission Computed Tomography/ Computed Tomography (SPECT/CT) * Yttrium-90 and isotopes (Y90) normal tissue and tumor Absorbed Dose using post-procedural PET/CT (or equivalent for Asia) scans
Study Type
OBSERVATIONAL
Enrollment
95
Intra-arterial Yttrium-90 glass microspheres
UCLA
Los Angeles, California, United States
University of Miami
Coral Gables, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting
Tumor response to TheraSphere® treatment will be assessed using Modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 depending on tumor type.
Time frame: 12 months follow up post last TheraSphere® treatment
Serious adverse events
Serious adverse events assessed as related or possibly related to TheraSphere®.
Time frame: 6 months follow up post last TheraSphere® treatment
Adverse events of interest
Specific adverse events assessed as related or possibly related to TheraSphere®, comprising of any of the following events: fatigue, pain, nausea, ascites, lymphopenia, hyperbilirubinemia, hypoalbuminemia.
Time frame: 6 months follow up post last TheraSphere® treatment
TheraSphere® Dosimetry in the subgroup of HCC participants
Dose absorbed to normal tissue and tumor, using the pre TheraSphere® 99mTc-MAA SPECT/CT, will be examined and compared to post TheraSphere® Y90 PET/CT (or equivalent in Asia) using the Simplicit90Y™ software.
Time frame: From up to 30 days until the date of TheraSphere® Treatment and Baseline
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Allina Health System Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Regents of the University of Minnesota
Minneapolis, Minnesota, United States
New York University School of Medicine
New York, New York, United States
University of Alberta
Edmonton, Alberta, Canada