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Therasphere will be administered via catheter through the Hepatic Artery to treat patients with Hepatocellular Carcinoma and Portal vein Thrombosis.
Therasphere consists of glass microspheres containing a radioactive material called Yttrium-90.
Therasphere is delivered into the liver tumor through a catheter placed into the hepatic artery which is the artery that provides the main blood supply to the tumor, this way delivering the radioactive material directly to the tumor and sparing the rest of the liver tissue from radiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therasphere | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraSphere | Device | TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate to the administration of Therasphere | Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival for patients with unresectable liver cancer. | Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year. | Participants will be followed through 1 year after receiving treatment |
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Inclusion Criteria:
18 yrs of age or older
Diagnosis of Hepatocellular Carcinoma
Portal Vein Thrombosis
ECOG performance < 2
->4 weeks since prior radiation, surgery or chemotherapy.
Life expectancy > 3 months
Able to provide written informed consent process in accordance with institutional review boards guidelines.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun s Kim, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29329568 | Derived | Xing M, Kokabi N, Camacho JC, Kim HS. Prospective longitudinal quality of life and survival outcomes in patients with advanced infiltrative hepatocellular carcinoma and portal vein thrombosis treated with Yttrium-90 radioembolization. BMC Cancer. 2018 Jan 12;18(1):75. doi: 10.1186/s12885-017-3921-1. | |
| 25847227 | Derived |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Kokabi N, Camacho JC, Xing M, El-Rayes BF, Spivey JR, Knechtle SJ, Kim HS. Open-label prospective study of the safety and efficacy of glass-based yttrium 90 radioembolization for infiltrative hepatocellular carcinoma with portal vein thrombosis. Cancer. 2015 Jul 1;121(13):2164-74. doi: 10.1002/cncr.29275. Epub 2015 Apr 6. |
| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |