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NCT03516695 Clinical Trial

RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry

Liver Cancer Clinical Trial

— READ90Y  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03516695
Other study ID # BTG-007509-01
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 23, 2018
Est. completion date December 12, 2018

Study information
Verified date April 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

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

Recruitment information / eligibility
Status Terminated
Enrollment 95
Est. completion date December 12, 2018
Est. primary completion date December 12, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Participant is = 18 years of age 2. Participant has confirmed liver cancer 3. Participant is able to provide informed consent according to local requirements/law 4. Participant has a life expectancy of = 3 months 5. Participant is scheduled to receive TheraSphere® treatment Exclusion Criteria: 1. Participant who has previously received Y90 microspheres 2. Participant who has consented to participate in a BTG-sponsored clinical study that includes TheraSphere® treatment

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TheraSphere®
Intra-arterial Yttrium-90 glass microspheres

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta
United States Rush University Medical Center Chicago Illinois
United States University of Miami Coral Gables Florida
United States Indiana University Indianapolis Indiana
United States UCLA Los Angeles California
United States 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

Sponsors (2)
Lead Sponsor Collaborator
Boston Scientific Corporation Biocompatibles UK Ltd

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Serious adverse events Serious adverse events assessed as related or possibly related to TheraSphere®. 6 months follow up post last TheraSphere® treatment
Secondary 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
Secondary 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
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