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

19 Years
75 Years
Open (Enrolling)
Brain Tumor

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Trial Information

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

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.

Inclusion Criteria:

1. High-grade gliomas, metastatic brain tumors, and other brain tumors refractory to
conventional medical therapy.

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

3. Subjects with metastatic cancer to the brain who have failed at least one
conventional therapy (surgery, stereotactic radio- surgery, chemotherapy, and/or
whole brain radiotherapy).

4. Four or fewer previously treated or untreated lesion(s) in the brain.

5. Tumor size ≤ 3.0 cm in largest diameter.

6. MR imaging is not contraindicated for the patient.

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

8. Able and willing to attend all study visits.

9. Karnofsky Performance Scale score >50.

10. Patients age 19 and older.

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 MRI scanner.

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

4. Known sensitivity to gadolinium-DTPA, or glomerular filtration rate not compatible
with receiving gadolinium-DTPA.

5. Based on Treatment Planning Imaging (MR and/or CT):

- Lesions localized in the brain stem.

- Lesions less than 5mm from primary branches of cerebral vessels, venous
sinus, hypophysis or cranial nerves.

- Presence of more than 4 brain tumors at the time of enrollment.

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Feasibility

Outcome Description:

Safety: To determine that the procedure can be safely tolerated without adverse events based on a 30, 90, 180 day 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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Pamela Z New, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Methodist Neurological Institute


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

January 2015

Related Keywords:

  • Brain Tumor
  • Laser Induced Thermal Therapy
  • Metastatic cancer
  • Brain Tumor
  • Visualase
  • Treatment resistant
  • Magnetic Resonance Thermal Imaging
  • Magnetic Imaging
  • Brain Neoplasms



Methodist Neurological Institute - Department of Neurosurgery Houston, Texas  77030