NCT00589212

GliaSite 1-3 Mets Study

A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hologic, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.

Detailed description

Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. In this case, it will irradiate the resected margins. Brain metastases not surgically removed will be then treated with radiosurgery

Conditions

• Brain Metastases

Interventions

Type	Name	Description
DEVICE	GliaSite Radiation Therapy System	GliaSite RTS is designed to deliver intracavitary radiation therapy for brain tumors. Following surgical resection, the balloon catheter is inflated to fill the cavity and Iotrex radiotherapy solution infused. It is a single applicator system that provides a uniform and conformal dose to the resection cavity.

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-03-01
• Completion: 2008-03-01
• First posted: 2008-01-09
• Last updated: 2008-06-11

Locations

1 site across 1 country: United States