TheraSpheres Treatment for Unresectable Hepatocarcinoma and Portal Vein Thrombosis
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Humanitarian Device Exemption Treatment Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma in Patients With Portal Vein Thrombosis|
- 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 ] [ Designated as safety issue: No ]
- Progression free survival for patients with unresectable liver cancer. [ Time Frame: Participants will be followed through 1 year after receiving treatment ] [ Designated as safety issue: No ]Patients will be followed after treatment at 1 month, 3 months, 6 months, and 1 year.
|Study Start Date:||March 2009|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556282
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Hyun s Kim, MD||Emory University|