Neoplasms

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Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

The target tumor/lesion will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. An MRI (Magnetic Resonance Imaging) is a exam that creates pictures using magnetic rays instead of x-rays. The tumor(s) will then be heated by the laser in an attempt to eliminate their presence. The physician will be able to see and control the temperature of the laser.

Visualase®

Pamela Z New, M.D.

The Methodist Hospital Neurological Institute is conducting a clinical trial for patients suffering from Metastatic brain tumors. The objective for this study is to evaluate the safety and feasibility of a MRI-guided laser thermal therapy during a real-time MRI guidance for the treatment of brain metastasis.

Patient will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. The tumor will then be heated by the laser and monitored by study physicians through the real-time MRI to see and control temperatures in the tissue. One in place, the thermal laser will then surgically remove the lesions. After the procedure, post treatment MR images will thenbe acquired for the determination of the effective treatment region.

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.

MRI-Guided LITT for Treatment Metastatic Brain Tumors

Use of MRI-Guided Laser Induced Thermal Therapy (LITT) for Metastatic Brain Tumors

Safety: To determine that the procedure can be safely tolerated without adverse events based on day 30 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.

30 day imaging evaluation of the laser induced lesion Correlation: examination of the extent to which Visulase predictions based on MRTI data match lesion dimensions from post-therapy MRI assessments. Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure. Local control of lesions at 30 day as defined by volume of lesion increasing by no more than 25%.

Accrual of patient survival post Visualase therapy.

The Methodist Hospital Research Institute

Neoplastic Processes

Magnetic resonance thermal imaging = MRTI

Laser ablation procedure taking about 1-3 hours, depending on the size and location of the tumor.

Laser Ablation

MRTI will be used to monitor the temperature within the ablation zone during the laser ablation.

Magnetic Resonance Thermal Imaging

Kamran Ahrar, MD

The goal of this clinical research study is to learn how well magnetic resonance thermal imaging (MRTI) can check the amount of tumor being destroyed using a therapy called laser ablation (a procedure that uses lasers to create heat that is designed to destroy cancer cells).

Laser ablation is designed to destroy tumor tissue with the use of fiber optics that are placed directly into the tumor to deliver laser light energy into the tissue.

In this study, tumor destruction will be checked using MRTI. MRTI is very similar to other MRI techniques, but instead of providing imaging data, MRTI will provide temperature data for cancerous areas in the body during the laser ablation process. If tumor temperature can be measured more accurately, the laser ablation process may be safer.

Laser Ablation and the MRTI Scan:

If you are found to be eligible to take part in this study, on the day you have laser ablation, you will have an intravenous (IV) line placed. You will receive sedation or general anaesthesia (drugs to make you sleep) through a needle in your vein over 1-3 hours to lessen any pain you may have during the procedure. This process will be explained to you.

After receiving the anaesthesia, the following tests and procedures will be performed:

* You will have a limited MRI.
* Your skin will be cleaned and covered with sterile towels and sheets to lower the chance of an infection.
* The doctor will use MRI scans to place a special needle (applicator) into the tumor. This applicator will be used to create heat at a high enough temperature that cells can be destroyed. Small masses may be destroyed in 1 treatment, but larger masses may require that the needle is placed several times. Each heating cycle takes less than 10 minutes.
* During laser ablation, MRTI will be used to monitor the temperature within the ablation zone. The MRTI process is very similar to regular MRI.
* Your heart rate and blood pressure will be measured during the entire procedure.
* The entire procedure may take about 1-3 hours, depending on the size and location of your tumor.

After the procedure is completed, you will be kept in the hospital for 4-6 hours for observation. You will be checked for recovery from the sedation that you received during the procedure. Once you have recovered from the procedure, you will be allowed to leave the hospital. If you have side effects from the procedure, the doctor may decide to keep you in the hospital for a longer time period for observation.

Follow-Up Visits:

After you have completed the procedure, you will return to M. D. Anderson for follow-up visits. About one (1) week after the laser ablation, you will have a physical exam and an X-ray. About one (1) month after the laser ablation, you will have a physical exam and a limited MRI to check the status of the disease.

Length of Study:

You will be considered off-study after the 1-month follow up visit.

This is an investigational study. The laser ablation procedure is an FDA-approved procedure. The devices are commercially available and can be used outside research studies. The investigational part of this study involves using MRTI to check the effect of ablation on the tumor. Up to 24 participants will be enrolled in this study. All will be enrolled at M.D. Anderson.

Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Ablation Therapy

A Study to Determine Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Therapy of Metastases to Bone

Magnetic resonance thermal imaging (MRTI) data to determine the correlation between observed temperatures determined from MRTI and the actual size of ablation as determined by post-ablation contrast-enhanced magnetic resonance imaging (MRI) during Laser Induced Thermal Therapy (LITT) of soft tissue metastases in bone.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI-Guided LITT for Treatment Metastatic Brain Tumors	NCT01736722	Brain Tumor	Visualase®	19 Years - 75 Years	The Methodist Hospital Research Institute
MRI-Guided LITT for Treatment Metastatic Brain Tumors	NCT01736722	Brain Tumor	Visualase®	19 Years - 75 Years	The Methodist Hospital Research Institute
Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Ablation Therapy	NCT00688038	Advanced Cancer Bone Metastases	Laser Ablation Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center
Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Ablation Therapy	NCT00688038	Advanced Cancer Bone Metastases	Laser Ablation Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center
MRI-Guided LITT for Treatment Metastatic Brain Tumors	NCT01736722	Brain Tumor	Visualase®	19 Years - 75 Years	The Methodist Hospital Research Institute
Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Ablation Therapy	NCT00688038	Advanced Cancer Bone Metastases	Laser Ablation Magnetic Resona...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for laser induced thermal therapy