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due to Sponsor's ongoing and upcoming projects and overall research priorities
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| Name | Class |
|---|---|
| Biocompatibles UK Ltd | INDUSTRY |
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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.
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:
Data for dosimetry determination will be collected on approximately 300 HCC participants to assess:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraSphere® | Device | Intra-arterial Yttrium-90 glass microspheres |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of TheraSphere® treatment in participants with liver cancers in a real-life setting | 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. | 12 months follow up post last TheraSphere® treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events | Serious adverse events assessed as related or possibly related to TheraSphere®. | 6 months follow up post last TheraSphere® treatment |
| Adverse events of interest | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with liver cancer for whom treatment with TheraSphere® has been prescribed and who meet all study eligibility criteria will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Riccardo Lencioni, MD | University of Miami (previously known affiliation) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| University of Miami |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| 6 months follow up post last TheraSphere® treatment |
| TheraSphere® Dosimetry in the subgroup of HCC participants | 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. | From up to 30 days until the date of TheraSphere® Treatment and Baseline |
| Coral Gables |
| Florida |
| 33146 |
| United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Allina Health System Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| Regents of the University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2C8 | Canada |
| D008107 |
| Liver Diseases |