RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry

Conditions
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Liver Cancer

Intervention / Treatment
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* Device: TheraSphere®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is ≥ 18 years of age Participant has confirmed liver cancer Participant is able to provide informed consent according to local requirements/law Participant has a life expectancy of ≥ 3 months Participant is scheduled to receive TheraSphere® treatment Exclusion Criteria: Participant who has previously received Y90 microspheres Participant who has consented to participate in a BTG-sponsored clinical study that includes TheraSphere® treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TheraSphere®|Intra-arterial Yttrium-90 glass microspheres|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months follow up post last TheraSphere® treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events | Serious adverse events assessed as related or possibly related to TheraSphere®. | 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. | 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. | From up to 30 days until the date of TheraSphere® Treatment and Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Liver Cancers, HCC, Dosimetry, Simplicit90Y™, TheraSphere®