RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry
- Conditions
- Liver Cancer
- Registration Number
- NCT03516695
- Lead Sponsor
- Boston Scientific Corporation
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 95
- Participant is ≥ 18 years of age
- Participant has confirmed liver cancer
- Participant is able to provide informed consent according to local requirements/law
- Participant has a life expectancy of ≥ 3 months
- Participant is scheduled to receive TheraSphere® treatment
- Participant who has previously received Y90 microspheres
- Participant who has consented to participate in a BTG-sponsored clinical study that includes TheraSphere® treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting 12 months follow up post last TheraSphere® treatment Tumor response to TheraSphere® treatment will be assessed using Modified Response Evaluation Criteria in Solid Tumors (mRECIST) or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 depending on tumor type.
- Secondary Outcome Measures
Name Time Method Adverse events of interest 6 months follow up post last TheraSphere® treatment Specific adverse events assessed as related or possibly related to TheraSphere®, comprising of any of the following events: fatigue, pain, nausea, ascites, lymphopenia, hyperbilirubinemia, hypoalbuminemia.
Serious adverse events 6 months follow up post last TheraSphere® treatment Serious adverse events assessed as related or possibly related to TheraSphere®.
TheraSphere® Dosimetry in the subgroup of HCC participants From up to 30 days until the date of TheraSphere® Treatment and Baseline Dose absorbed to normal tissue and tumor, using the pre TheraSphere® 99mTc-MAA SPECT/CT, will be examined and compared to post TheraSphere® Y90 PET/CT (or equivalent in Asia) using the Simplicit90Y™ software.
Trial Locations
- Locations (8)
University of Miami
🇺🇸Coral Gables, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Regents of the University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
New York University School of Medicine
🇺🇸New York, New York, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Allina Health System Virginia Piper Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
UCLA
🇺🇸Los Angeles, California, United States