NCT00877136

A Treatment of Unresectable Hepatocellular Carcinoma With TheraSphere®

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: St. Joseph Hospital of Orange · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an interdisciplinary study that falls into the Humanitarian Use Device category. There are no hypotheses to be tested in this treatment protocol. The study has the following objectives: 1. Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates. 2. Evaluate patient experience and toxicities associated with TheraSphere® treatment. 3. Measure tumor response rates

Detailed description

The purpose of this protocol is to provide supervised access at this institution to TheraSphere® treatment for a heterogeneous population of patients with unresectable primary liver tumors, with the liver being the only dominant site of disease. Based on experience gained in previous studies and well-established interventional radiology techniques, this protocol allows multiple treatments with TheraSphere® that may be delivered on an inpatient or out patient basis. Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 - 90 days apart. The investigator, working with co-investigators in radiation oncology, interventional radiology and nuclear medicine, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy, and the desired goal of treatment.

Conditions

• Liver Tumors
• Hepatocellular Carcinoma
• Hepatoma
• Neoplasms

Interventions

Type	Name	Description
DEVICE	TheraSphere®	TheraSphere® consists of insoluble glass microspheres where yttrium-90 is an integral constituent of the glass. TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. This artery provides the main blood supply to the tumor in the liver. TheraSphere® being unable to traverse the tumor vasculature is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.

Timeline

• Start date: 2009-02-01
• Primary completion: 2015-02-01
• Completion: 2021-03-01
• First posted: 2009-04-07
• Last updated: 2021-04-06

Locations

1 site across 1 country: United States