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Sponsors and Collaborators: |
Hologic Methodist Healthcare |
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Information provided by: | Hologic |
ClinicalTrials.gov Identifier: | NCT00589212 |
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.
Condition | Intervention | Phase |
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Brain Metastases |
Device: GliaSite Radiation Therapy System |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study Utilizing Focal Radiation in Patients With 1-3 Brain Metastases |
Estimated Enrollment: | 50 |
Study Start Date: | October 2003 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients with 1-3 brain metastases
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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.
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Methodist University Hospital | |
Memphis, Tennessee, United States, 38104 |
Principal Investigator: | Allen K Sills, Jr., MD | University Hospital |
Responsible Party: | University Hospital ( Allen K. Sills, Jr. MD ) |
Study ID Numbers: | GS-700 |
Study First Received: | December 24, 2007 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00589212 History of Changes |
Health Authority: | United States: Food and Drug Administration |
GliaSite Brain metastases 1-3 METS |
Brain Neoplasms Neoplasm Metastasis Central Nervous System Diseases |
Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
Brain Neoplasms Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Nervous System Diseases |
Neoplasm Metastasis Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |