- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516695
RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry (READ90Y)
Study Overview
Detailed 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2C8
- University of Alberta
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California
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Los Angeles, California, United States, 90095
- UCLA
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Florida
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Coral Gables, Florida, United States, 33146
- University of Miami
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Regents of the University of Minnesota
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Minneapolis, Minnesota, United States, 55407
- Allina Health System Virginia Piper Cancer Institute
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting
Time Frame: 12 months follow up post last TheraSphere® treatment
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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.
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12 months follow up post last TheraSphere® treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serious adverse events
Time Frame: 6 months follow up post last TheraSphere® treatment
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Serious adverse events assessed as related or possibly related to TheraSphere®.
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6 months follow up post last TheraSphere® treatment
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Adverse events of interest
Time Frame: 6 months follow up post last TheraSphere® treatment
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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.
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6 months follow up post last TheraSphere® treatment
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TheraSphere® Dosimetry in the subgroup of HCC participants
Time Frame: From up to 30 days until the date of TheraSphere® Treatment and Baseline
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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.
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From up to 30 days until the date of TheraSphere® Treatment and Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Riccardo Lencioni, MD, University of Miami (previously known affiliation)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTG-007509-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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