RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry



Status:Terminated
Conditions:Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/20/2019
Start Date:February 23, 2018
End Date:December 12, 2018

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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.

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

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
We found this trial at
8
sites
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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Coral Gables, Florida 33146
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Coral Gables, FL
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Edmonton, Alberta T6G 2J2
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Edmonton,
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Los Angeles, California 90095
(310) 825-4321
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Los Angeles, CA
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800 East 28th Street
Minneapolis, Minnesota 55407
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Minneapolis, MN
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Minneapolis, Minnesota 55455
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Minneapolis, MN
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
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New York, NY
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