TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis
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|ClinicalTrials.gov Identifier: NCT01556282|
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : May 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Portal Vein Thrombosis||Device: TheraSphere||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.
Other Name: There are no other names for this device.
- Response rate to the administration of Therasphere [ Time Frame: Participants will be followed through 1 year after the procedure at 1 month, 3 months, 6 months and 1 year visits ]
- Progression free survival for patients with unresectable liver cancer. [ Time Frame: Participants will be followed through 1 year after receiving treatment ]Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556282
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Hyun s Kim, MD||Emory University|