In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors that cannot be removed by surgery. Researchers want to find out if it is possible to use this new device in subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
North Shore University Hospital
Manhasset, New York, United States
RECRUITINGRate of technical success or failure to complete the initial procedure with no associated major complications.
Time frame: within 24 hours following the procedure
Examination of the extent to which Visualase predictions based on MRTI data match lesion dimensions form post-therapy MRI assessments.
Time frame: Immediately following treatment (day 0)
Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure
Time frame: from day 0 to patient release
Local control of treated lesions as defined by volume of lesions increasing by no more than 25%
Time frame: Day 30, 90, and 180 days post procedure
Accrual of patient survival post Visualase therapy
Time frame: Sooner of 3 years or patient death
Procedure-related morbidity and mortality
Time frame: 30, 90,180 days post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.