Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Central Nervous System Neoplasms

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

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Carcinoma, Ductal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

Patients undergo MR-thermal image guided LITT over 1 hour.

magnetic resonance thermal imaging

laser interstitial thermal therapy

Hiroyuki Abe

This pilot clinical trial studies magnetic resonance thermal image guided laser interstitial thermal therapy in treating patients with breast cancer. Magnetic resonance thermal image guided laser interstitial thermal therapy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue

PRIMARY OBJECTIVES:

I. To evaluate the procedural success rate of using the Visualase magnetic resonance (MR)-guided laser system to target, access, thermally monitor, and focally ablate MR-visible breast cancer lesions.

2. To obtain preliminary data on ablative success using pathologic assessment for specimen excised subsequent to the ablation.

OUTLINE:

Patients undergo MR-thermal image guided laser interstitial thermal therapy (LITT) over 1 hour.

After completion of study treatment, patients are followed up at 3-7 days.

Magnetic Resonance Thermal Image Guided Laser Interstitial Thermal Therapy in Treating Patients With Breast Cancer

A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer

Moderate degree of skin burn which requires medical intervention will be considered side effects for stopping purposes.

National Cancer Institute (NCI)

University of Chicago

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.

BioTex, Inc.

M.D. Anderson Cancer Center

Laser Interstitial Thermal Therapy (LITT) - An intraoperative biopsy and placement of applicator for laser treatment. Treatment will last between 5 and 10 minutes.

An intraoperative biopsy and placement of applicator for laser treatment. Treatment will last between 5 and 10 minutes.

Visualase® Thermal Therapy System

Jeffrey Weinberg, MD

The goal of this clinical research study is to learn about a new therapy device called the Visualase® Thermal Therapy System (a device that uses a laser to kill tumor cells and is guided using magnetic resonance thermal imaging \[MRTI\]). The Visualase® Thermal Therapy System is used to treat metastatic brain tumors. Researchers want to find out if it is possible to use this new device in patients with metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.

The Study Device and Process:

The Visualase® Thermal Therapy System combines 3 FDA-approved devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) beams to the tumor tissue; the PhoTex 15 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 patients 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.

LITT is less invasive than an open surgical procedure. There are no radiation-related side effects, or limits on the number of times it can be repeated. Also, since the procedure is performed using the MRTI, doctors can find out right away how effective the therapy was by using special imaging sequences, which may also show any surviving tumor cells.

Screening:

Before you can enroll on this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed within 14 days before your treatment:

* Your medical history will be recorded, and you will be asked questions about any other treatment you have had for the metastatic brain tumor(s).
* You will have a complete physical exam.
* You will have a neurological exam. This will include an exam of the function of the nerves in your head, an exam of your visual fields, and tests of your reflexes, muscle strength, and senses.
* You will have an MRI scan of your brain within 30 days before LITT therapy.
* Women who are able to have children must have a negative urine pregnancy test within 48 hours (2 days) before treatment.

Study Treatment:

If you are found to be eligible to take part in the study, you will be scheduled for treatment of the brain tumor(s) using the Visualase® Thermal Therapy System.

You will be brought to a special operating room called the BrainSUITE®. The BrainSUITE® is a regular operating room that has a built-in MRI machine that can be used for taking pictures during the surgery. The imaging and procedure will be performed while you are under anesthesia (either deep sedation or fully "asleep").

A standard tumor biopsy will be performed. Then, using the same needle holder, the laser applicator will be placed within the tumor. MRI scans will be taken to make sure the applicator is placed properly. The biopsy and applicator placement will take about 1 hour.

After that, the laser treatment will be performed. At the same time, MRI scans will be taken during the procedure. The treatment will last between 5 and 10 minutes. After treatment, follow-up MRI scans will be taken, which may take 30-60 minutes longer. If any tumor tissue is left over, the laser may be moved slightly and a second treatment performed. Once completed, the needle will be removed, and your incision will be closed in the standard way.

If the tumor biopsy results reveal that the tumor has not come back, LITT will not be performed. Other treatment options which are available to you will be discussed with your doctor prior to the surgery.

Study Tests:

After the laser treatment, you will be observed in the hospital for 24 hours. While you are in the hospital, at about 1 day after treatment, you will have a physical and neurological exam, as well as a computed tomography (CT) scan of your brain (without using a contrast dye injected in the bloodstream) to make sure there were no problems with treatment. This is standard after any biopsy.

Follow-Up Testing:

You will be seen by your doctor for follow-up testing at about 1 week, 1 month, 3 months, and 6 months after your treatment. It will be very important for you to return to see your doctor at your scheduled visits, even if you are feeling fine. At the follow-up visits, your doctor will perform a complete physical and neurological exam. You will also have an MRI at all visits, starting with the 1-month visit.

This is an investigational study. Each part of the Visualase® Thermal Therapy System is FDA approved for use in delivering LITT to patients. Up to 22 patients will take part in this clinical research study. All will be enrolled at M. D. Anderson.

Magnetic Resonance Temperature Imaging & Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

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

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

MR-guided Laser Interstitial Thermal Therapy System

Paul Legmann, M.D.

The purpose of this study is to determine if the, MR guided, laser interstitial thermal therapy (LITT) treatment technique can be safety and efficiently used for the human liver metastasis

This new "minimally invasive" technique has been tested so far, with success, on animal brain and prostate tumors. LITT has also tested with success by other teams for the treatment of liver metastasis.

The main purpose of this study is to determine if the Visualase, MR guided, laser interstitial thermal therapy device can be safely and efficiently used for the treatment of human liver metastasis originating from the colon and rectal primary tumors.

As secondary objectives for this clinical study is to explore the tolerance of the treatment and its contra indications.

The clinical trial will include a statistical sample of 25 patients and will run over a period of 24 months. The inclusion period will be of 12 months and the patients will be followed up during a period of 7 days after the intervention.

The clinical trial will be performed at the Cochin University Hospital of Paris and the patients will be coming from the oncology / surgery departments of the hospital.

The patients recruited for this study are those who developed several liver metastasis and are planned for the a surgical resection for part of the liver (where metastasis are located). Prior to the surgical resection, a LITT procedure will be performed on one of the metastasis. After the surgical resection histological analysis will be elaborated to compare the real necrosis volume created by the LITT procedure to the expected predicted volume.

Laser Interstitial Thermal Therapy Under "Real Time" MRI Guidance for "Minimal Invasive" Treatment of Liver Metastasis

The Clinical Evaluation of the Laser Interstitial Thermal Therapy (LITT ), Under "Real Time" MRI Guidance, for the "Minimal Invasive" Treatment of Liver Metastasis - a Phase IIa Mono-centric Study, Without Direct Benefice to the Patient

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
Magnetic Resonance Thermal Image Guided Laser Interstitial Thermal Therapy in Treating Patients With Breast Cancer	NCT01791998	Ductal Breast C... Invasive Ductal... Stage IA Breast... Stage IB Breast...	magnetic resona... laser interstit...	-	University of Chicago
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
Magnetic Resonance Temperature Imaging & Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors	NCT00720837	Brain Tumor	Visualase® Ther...	-	M.D. Anderson Cancer Center
Magnetic Resonance Thermal Image Guided Laser Interstitial Thermal Therapy in Treating Patients With Breast Cancer	NCT01791998	Ductal Breast C... Invasive Ductal... Stage IA Breast... Stage IB Breast...	magnetic resona... laser interstit...	-	University of Chicago
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
Laser Interstitial Thermal Therapy Under "Real Time" MRI Guidance for "Minimal Invasive" Treatment of Liver Metastasis	NCT00392366	Carcinoma, Hepa... Liver Neoplasms Digestive Syste...	MR-guided Laser...	18 Years -	BioTex, Inc.

Spots Global Cancer Trial Database for magnetic resonance thermal imaging