NCT01349075

TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma

A Humanitarian Device Exemption Treatment Protocol of Therasphere for the Treatment of Unresectable Hepatocellular Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 474 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TheraSphere is a medical device containing yttrium-90 (Y-90) a radioactive material that has been used to treat liver tumors. When Y-90 is put into very tiny glass beads (TheraSphere), it can be injected into the liver through a blood vessel. This allows a large local dose of radiation to be delivered to the tumor with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.

Detailed description

Surgical resection of the affected portion of the liver offers the best chance for disease-free survival in patients with hepatoma (HCC). Unfortunately, most hepatoma patients present with disease that is not amenable to resection (multifocal disease) or have other medical contraindications to surgery (limited hepatic reserve related to advanced cirrhosis or chronic hepatitis). Fewer than 15%1 of hepatoma patients are suitable surgical candidates. The objective of treatment with TheraSphere is to selectively administer a potentially lethal dose of radioactive material to neoplastic tissue in the liver of patients with HCC. Regional therapies for HCC may have several advantages over systemically administered treatments. Irradiating a cancer prior to treatment with regional chemotherapy may be more effective than either therapeutic modality alone. TheraSphere 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
RADIATION	TheraSphere	The target dose of TheraSphere most commonly used is 120 - 140 Gy. Standard radiation safety techniques will be used.

Timeline

• Start date: 2007-10-01
• Primary completion: 2021-03-15
• Completion: 2021-03-15
• First posted: 2011-05-06
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States