HDE Use Protocol of TheraSphere for Treatment of Unresectable HCC
MDS Nordion's TheraSphere, Yttrium-90 glass microspheres has been approved as a Humanitarian device authorized by federal(USA)law for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma(HCC)who can have placement of appropriately positioned hepatic arterial catheters. Outcomes of this treatment protocol will be monitored and reported to the Carolinas HealthCare System Institutional Review Board.
|Study Design:||Observational Model: Case-Only|
|Official Title:||A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma|
- Progression of liver cancer [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Occurrence of unacceptable side effects after treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||January 2009|
|Estimated Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Total number of patients enrolled
Device: 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.
Other Name: MDS Nordion's TheraSphere
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 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.