Use of MRI-Guided Laser Induced Thermal Therapy (LITT) for Metastatic Brain Tumors
This is a study for evaluating the feasibility and safety of MR-guided laser thermal
ablation of treatment-resistant brain tumors using the Visualase® Thermal Therapy System
(Manufactured by BioTex, Inc., Houston, TX). The Visualase system is FDA cleared for soft
tissue ablation in a number of surgical specialties including Neurosurgery (see appendix for
documentation). Patients with intracranial brain tumors measuring 3 cm or smaller in largest
diameter that have failed any conventional therapy (surgery, stereotactic radiosurgery
and/or whole brain radiotherapy) are eligible.
The target tissue containing the tumor will undergo MRI-guided laser induced thermal
therapy. MR imaging is used to define the treatment volume as well as plan and verify
placement of the applicator. The extent of ablation is quantitatively monitored and
displayed during delivery using real-time, MR temperature imaging. MR temperature imaging
will also be used to monitor and control the temperature of adjacent tissues. Treatment will
be automatically stopped if the MR temperature feedback system reports the temperature in
the adjacent tissue has risen above a preset threshold. Treatment can be manually stopped by
the neurosurgeon monitoring the treatment in real-time at any point during the procedure by
simply turning off the power to the laser from the Visualase® system console. After laser
delivery, MR images can be used to verify the extent of treatment and plan a therapy
delivery if necessary.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and Feasibility
Safety: To determine that the procedure can be safely tolerated without adverse events based on a 30, 90, 180 day procedure-related morbidity and mortality. Feasibility: To determine that the the rate of technical success or failure to complete the initial procedure with no associated major complications.
Pamela Z New, M.D.
Methodist Neurological Institute
United States: Food and Drug Administration
|Methodist Neurological Institute - Department of Neurosurgery||Houston, Texas 77030|