Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-30 @ 2:58 AM
Study NCT ID:
NCT01176604
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2010-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yttrium Y 90 Glass Microspheres in Treating Patients With Unresectable Hepatocellular Carcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Humanitarian Device Exemption Treatment Protocol of TheraSphere® for Treatment of Unresectable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2022-10
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:
This trial studies how well yttrium Y 90 glass microspheres work in treating patients with hepatocellular carcinoma that cannot be removed by surgery. Radioactive drugs, such as yttrium Y 90 glass microspheres, may carry radiation directly to cancer cells and not harm normal cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. Provide oversight to treatment with yttrium Y 90 glass microspheres (TheraSphere) to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.
II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.
OUTLINE:
Patients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-6 weeks, then annually for up to 2 years.
I. Provide oversight to treatment with yttrium Y 90 glass microspheres (TheraSphere) to eligible patients with hepatocellular carcinoma (HCC) of the liver who are not surgical resection candidates.
II. Evaluate patient experience, toxicities and overall survival associated with TheraSphere treatment.
OUTLINE:
Patients receive yttrium Y 90 glass microspheres via a catheter over 5 minutes on day 0. Patients may receive additional treatments at 4-12 week intervals until all tumors in the liver have been treated in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-6 weeks, then annually for up to 2 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01816 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2008-0770 | OTHER | M D Anderson Cancer Center | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |