Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-02 @ 1:41 PM
Study NCT ID:
NCT00605150
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2008-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HDE Use Protocol of TheraSphere for Treatment of Unresectable HCC
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Humanitarian Device Exemption (HDE) Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: