Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-06-16 @ 6:33 PM
Study NCT ID:
NCT00701168
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2017-08-23
First Post:
2008-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer
Sponsor:
Leo W. Jenkins Cancer Center
Organization:
Study Overview
Official Title:
A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2017-08
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:
The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: