Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-02 @ 10:30 AM
Study NCT ID:
NCT03516695
Status:
TERMINATED
Last Update Posted:
2021-04-21
First Post:
2018-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to Sponsor's ongoing and upcoming projects and overall research priorities
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
READ90Y
Brief 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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: