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 |
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.
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
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
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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800 East 28th Street
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
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New York University School of Medicine NYU School of Medicine has a proud history that...
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