Liver Cancer
Conditions
Keywords
Registry, Liver Cancers, HCC, Dosimetry, Simplicit90Y™, TheraSphere®
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
Interventions
DEVICETheraSphere®
Intra-arterial Yttrium-90 glass microspheres
Sponsors
Biocompatibles UK Ltd
Boston Scientific Corporation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events | 6 months follow up post last TheraSphere® treatment | Serious adverse events assessed as related or possibly related to TheraSphere®. |
| 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. |
| 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. |
Countries
Canada, United States
Outcome results
None listed