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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
BioTex, Inc. |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00720837 |
Purpose
Investigate hypothesis that real-time, MR-guided laser induced thermal ablation of brain lesions under real-time thermal imaging guidance is both a feasible and safe minimally-invasive technique for local, highly conformal therapy of metastatic brain tumors.
| Condition | Intervention |
|---|---|
|
Brain Tumor |
Procedure: Visualase® Thermal Therapy System |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging (MRTI) and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors |
| Estimated Enrollment: | 22 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Laser Interstitial Thermal Therapy (LITT)
|
Procedure: Visualase® Thermal Therapy System
An intraoperative biopsy and placement of applicator for laser treatment. Treatment will last between 5 and 10 minutes.
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Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jeffrey Weinberg, MD | 713-792-2400 |
| United States, Texas | |
| U.T. M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Jeffrey Weinberg, MD | |
| Principal Investigator: | Jeffrey Weinberg, MD | U.T. M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T. M.D. Anderson Cancer Center ( Jeffrey Weinberg, MD / Associate Professor ) |
| Study ID Numbers: | 2007-0610 |
| Study First Received: | July 21, 2008 |
| Last Updated: | May 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00720837 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Brain Tumor Brain Cancer MR-guided laser thermal ablation of brain tumors Visualase® Thermal Therapy System Magnetic Resonance Thermal Imaging |
MRTI Visualase Cooled Laser Application System Laser Interstitial Thermal Therapy LITT |
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Brain Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases |
Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |