NCT00683631

TheraSphere HUD For Treatment of Unresectable Hepatocellular Carcinoma (HCC)

TheraSphere HUD For Treatment of Unresectable HCC

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 183 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this protocol is to provide access to Therasphere treatment for patients with liver tumors.

Detailed description

Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with primary liver cancer (hepatocellular carcinoma (HCC)). Unfortunately, most of these patients present with disease that is not amenable to surgery (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15% of HCC patients are suitable surgical candidates. The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to cancerous tissue in the liver of patients with HCC. This type of regional therapy may have several advantages over systemically administered treatments and may also be of value as a 'bridging' treatment for HCC patients awaiting a donor organ for liver transplantation.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
OTHER	TheraSphere HUD	TheraSphere is FDA approved under a Humanitarian Use Device. It is considered a brachytherapy device that delivers intra-arterial radiation therapy using yttrium-90 microspheres directly to liver tumors.

Timeline

• Start date: 2004-01-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2008-05-23
• Last updated: 2023-12-18

Locations

1 site across 1 country: United States