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Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

Phase 1/Phase 2
Open (Enrolling)
Brain Neoplasms

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Trial Information

Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

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.

Inclusion Criteria:

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

- Subjects with metastatic cancer to the brain who have failed at least one
conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain

- Three or fewer previously treated or untreated lesion(s) in the brain.

- Tumor size ≤ 3.0 cm in largest diameter.

- MR imaging is not contraindicated for the patient.

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

- Able and willing to attend all study visits.

- Karnofsky Performance Scale score >70 for patients over the age of 15.

- Lansky Play Scale >70 for patients 15 years of age or younger.

Exclusion Criteria:

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

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

- 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.

- Known sensitivity to gadolinium-DTPA.

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

- 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.

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

- Evidence of recent (<2 weeks) hemorrhage.

- Presence of more than 3 brain tumors at the time of enrollment.

- Symptoms and signs of increased intracranial pressure.

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

- Patients who are unable to receive corticosteroids.

- 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:

Rate of technical success or failure to complete the initial procedure with no associated major complications.

Outcome Time Frame:

within 24 hours following the procedure

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

September 2008

Completion Date:

September 2010

Related Keywords:

  • Brain Neoplasms
  • brain
  • metastasis
  • neoplasm
  • tumor
  • Patients with secondary brain neoplasms
  • laser therapy
  • laser interstitial thermal therapy
  • Brain Neoplasms
  • Neoplasms



North Shore University Hospital Manhasset, New York  11030