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

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.

Inclusion Criteria:

1. Patient or family able and willing to give informed consent.

2. Subjects with metastatic cancer to the brain who have failed at least one
conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain
radiotherapy). Failure is defined as local recurrence or failure of the previously
treated lesion and will be determined by the treating surgeon based on a review of
patient history and imaging.

3. Tumor size
4. MR imaging is not contraindicated for the patient

5. Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as
determined by the treating surgeon.

6. Able and willing to attend all study visits.

7. Karnofsky Performance Scale score >/=70 for patients over the age of 15.

8. Lansky Play Scale>/=70 for patients 15 years of age or younger.

Exclusion Criteria:

1. Patients or family unwilling or unable to give written consent.

2. Patients who cannot physically fit in, or are too heavy for, the BrainSUITE® MRI
scanner

3. Patients with contra-indications to MRI imaging, such as, but not limited to,
pacemakers or defibrillators, non-compatible aneurysm clips, shrapnel, or other
internal ferromagnetic objects

4. Known sensitivity to gadolinium-DTPA

5. Based on Treatment Planning Imaging (MR and/or CT) done on the day of treatment:
-Brain edema and/or mass effect that causes midline shift or shift in wall of
ventricle of more than 5 mm. -Lesions localized in the brain stem or the posterior
fossa. -Lesions less than 5mm from primary branches of cerebral vessels, venous
sinus, hypophysis or cranial nerves. -Evidence of recent (<2 weeks) hemorrhage.

6. Symptoms and signs of increased intracranial pressure

7. Medical issues which prohibit the patient from undergoing surgery (as determined by
the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).

8. Patients who are unable to received corticosteroids.

9. Positive pregnancy test for women of child-bearing age.