HDE Use Protocol of TheraSphere for Treatment of Unresectable HCC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00605150|
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : February 16, 2015
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma||Radiation: TheraSphere-Yttrium 90 microsphere|
The objectives of this study are to provide supervised access to treatment with TheraSphere to eligible patients with Hepatocellular Carcinoma of the liver who are not surgical resection candidates and to evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.
This is an observational treatment use protocol that will provide Institutional Review Board (IRB) oversight and documentation of the clinical experience of patients undergoing treatment for liver carcinoma using TheraSphere. Participation involves no investigational or research procedures. Patients will be followed for treatment-related adverse experiences and will be monitored in accordance with institutional practices. Approximately 60 patients will be enrolled in a treatment protocol and the number may be expanded following completion of the first cohort. The total number of patients to be treated will be determined based on clinical experience and patient outcomes. There are no control subjects in this treatment protocol.
The duration of the protocol will depend on patient experience with this treatment. An initial one year approval is sought at this time. Patient experience will be evaluated continuously and if the clinicians find that the treatment provides benefits to patients, renewal of the approval will be sought after the first 12 months.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||A Humanitarian Device Exemption (HDE) Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Total number of patients enrolled
Radiation: TheraSphere-Yttrium 90 microsphere
TheraSphere is delivered to the liver via a catheter placed into the femoral artery and guided by fluoroscopy to the hepatic artery. Once the catheter is properly positioned, the physician infuses TheraSphere, which localizes preferentially in the tumor.
- Progression [ Time Frame: 6 months ]Progression of liver cancer
- Number of Participants With Unacceptable Side Effects After Treatment [ Time Frame: 6 months ]
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): NCT00605150
|Principal Investigator:||David A Iannitti, MD||Carolinas Medical Center|