Trials / Terminated
TerminatedNCT03516695
RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 95 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TheraSphere® | Intra-arterial Yttrium-90 glass microspheres |
Timeline
- Start date
- 2018-02-23
- Primary completion
- 2018-12-12
- Completion
- 2018-12-12
- First posted
- 2018-05-04
- Last updated
- 2021-04-21
Locations
8 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT03516695. Inclusion in this directory is not an endorsement.