Clinical trial NCT03516695: RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
Official title: RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Cancer
Keywords: Registry
Liver Cancers
HCC
Dosimetry
Simplicit90Y™
TheraSphere®
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Biocompatibles UK Ltd
First posted: 2018-05-04
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with liver cancer for whom treatment with TheraSphere® has been prescribed and who meet all study eligibility criteria will be enrolled.

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

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting
timeFrame: 12 months follow up post last TheraSphere® treatment
Secondary outcomes:
measure: Serious adverse events
timeFrame: 6 months follow up post last TheraSphere® treatment
measure: Adverse events of interest
timeFrame: 6 months follow up post last TheraSphere® treatment
measure: TheraSphere® Dosimetry in the subgroup of HCC participants
timeFrame: From up to 30 days until the date of TheraSphere® Treatment and Baseline
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Minneapolis
country: United States
facility: Allina Health System Virginia Piper Cancer Institute
state: Minnesota
city: Minneapolis
country: United States
facility: Regents of the University of Minnesota
state: Minnesota
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Miami (previously known affiliation)
name: Riccardo Lencioni, MD
role: PRINCIPAL_INVESTIGATOR
References: