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RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry — READ90Y  

Liver Cancer Clinical Trial

Official title:
RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03516695
Study type Observational
Source Boston Scientific Corporation
Contact
Status Terminated
Phase
Start date February 23, 2018
Completion date December 12, 2018
View Details
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