Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
The Visualase Thermal Therapy System is FDA-cleared for thermal destruction of soft tissue
in neurosurgery under MRI guidance. The device combines 3 previously FDA-cleared devices:
the Visualase Cooled Laser Application System, which delivers the laser (energy) to the
tumor tissue; the PhoTex , Diode Laser Series, which is the laser itself; and the Visualase
ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor
your treatment.
The Visualase Thermal Therapy System will be used in this study to give subjects a type of
therapy called Laser Interstitial Thermal Therapy (LITT). LITT uses laser light to heat and
destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT,
small fiber-optic applicators are placed directly into the tumor and heating is performed
from the inside out, which may lead to the destruction of the tumor. During the heating
process, MRTI can be used to watch the temperatures around the applicator to make sure that
the tumor receives enough treatment and that the normal tissues around the tumor do not get
too hot.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of technical success or failure to complete the initial procedure with no associated major complications.
within 24 hours following the procedure
No
United States: Institutional Review Board
VIS-BR-08-001
NCT00787982
September 2008
September 2010
Name | Location |
---|---|
North Shore University Hospital | Manhasset, New York 11030 |