Our specific aims are
to test the following hypotheses: Hypothesis 1: A tumor can be
completely ablated by ILT with MRI-guidance; Hypothesis 2: The
MRI-based 3D temperature map of tissue during ILT is predictive of
destruction; Hypothesis 3: The 3D “thermal dose” map that is based on
the tissue’s temperature over time is more predictive of tissue
destruction than the temperature map.

Condition	Intervention
Brain Tumor	Device: Interstitial Laser Therapy

Further study details as provided by Brigham and
Women's Hospital:

Primary Outcomes: A tumor can be completely
ablated by ILT with MRI-guidance
Secondary
Outcomes: Patients undergoing ILT will be assessed pre- and
post-operatively based on a neurological exam by a physician and
patient self-assessment using the Glioma Outcomes Questionnaire.
Expected Total Enrollment:  24

The
goal is to evaluate the use of minimally invasive interstitial laser
therapy (ILT) in the brain. Our group is in a unique position to offer
image-guided ILT because of our expertise and resources here at Brigham
& Women's Hospital in the Departments of Neurosurgery and
Radiology. The therapy will be monitored and controlled by the use of
magnetic resonance imaging (MRI). ILT is a minimally invasive procedure
in which the targeted tissue is thermally destroyed in situ in a
controlled fashion. The intra-operative MRI provides a way to “see” the
treatment. It can be used to treat disease by guiding surgery by
providing images of tissue changes during therapy.

In spite of its appeal as a minimally
invasive technique, MRI-guided ILT is not commonly practiced in the
United States. One reason is that proper clinical implementation of ILT
requires an operating room (OR) setting and an MRI scanner – a very
rare combination. Our MRI-OR suite includes a sterile procedure room
with a 0.5 Tesla vertically “open” magnet. In the past, we have
performed MRI-guided ILT procedures in 9 patients. While few in number,
this is the most extensive U.S. experience in ILT in the brain.

We have recently created a new image
networking and display package for the visualization of 3D information
during laser therapy. This provides a view of multiple image planes
taken through the tissue volume around the fiber tip.

Each patient will undergo ILT. The
procedure will be performed under anesthesia as per standard
procedures. The surgical placement of the laser fiber is a procedure
identical to the well-developed and practiced technique of brain
biopsy. A hole approximately 1 cm in diameter will be drilled in the
skull through which the laser fiber will be placed under image guidance
to confirm the actual progress during the advance of the fiber. We will
deliver energy at a rate and distribution of 1-12 watts/cm for
exposures less than 20 minutes. After the laser has been turned off,
and the tissue cooled, MRI will show the region of ablation. As needed,
the laser fiber will be moved/re-located to assure that the total
target has been ablated. After the treatment is complete, the fiber is
withdrawn, final images are acquired and the surgical site is closed
and dressed. On the day after the procedure, the patient will undergo a
24 hr follow-up MRI exam. There will be post-operative care as with any
neurosurgical patient.

The following continuous variables will be measured in this study.

• the pre-operative tumor volume (VO) in cc
• the post-operative ablated volume (V1) in cc
• the intra-operative critical temperature volume (VT) in cc
• the intra-operative critical dose
  volume (VD) in cc.

The following statistical hypothesis tests will be conducted.

Statistical Hypothesis 1. A tumor can be completely ablated by ILT
with MRI-guidance.

We
propose that the difference between the mean the pre-op tumor volumes
and the post-op ablated volumes (VO and V1, respectively) is zero.
Residual tumor is defined as (V0-V1). This will be determined by
calculating the mean of the values of the proportion of residual tumor,
defined as (V0-V1)/ V0.Use of the proportion normalizes the data for
different sized tumors.

Statistical Hypothesis 2. The MRI-based
3-D temperature map of the tissue during ILT is predictive of
destruction. We propose that the difference between the mean post-op
ablated volumes and the intra-operative critical temperature volumes
(VT and V1, respectively) is zero. This will be determined by
calculating the mean of the values of the proportion of the difference
between them, defined as (VT-V1)/VT.

Statistical Hypothesis 3. The thermal dose map is predictive of
tissue destruction.

We
propose that the difference between the mean post-op ablated volumes
and the intra-operative critical dose volumes (VD and V1, respectively)
is zero. This will be determined by calculating the mean of the values
of the proportion of the difference between them, defined as (VD-V1
/VD).

Also, data will be collected through Neurological Examinations and
GOC Questionnaire.

Ages Eligible for
Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Male or female Age 18+ Surgically difficult to access tumors
including intracerebral metastases and vascular malformations

–

Exclusion Criteria:

Patients
unwilling or unable to give written consent Patients at risk for
cardiac ischemia Patients who cannot physically fit in the MRI scanner
in the MRI OR Patients with contra-indications to MRI imaging such as
pacemakers, non-compatible aneurysm clips, shrapnel, and other internal
ferromagnetic objects Patients with coagulopathies, severe medical
problems, cardiac arrythmias or abnormal BUN –

Please refer to this study by ClinicalTrials.gov
identifier  NCT00207350

Joanne E O'Hara, M.A.      617-732-6992    johara1@partners.org
Donna Dello Iacono, RN, MS      617-732-6826    ddelloiacono@partners.org

Massachusetts
      Brigham & Women's Hospital, Boston,  Massachusetts,  02115, 
United States; Recruiting

Study chairs or principal investigators

Peter M Black, MD, PhD,  Principal Investigator,  Brigham and Women's
Hospital   

Study ID Numbers:  2001-P-001794
Last Updated:  December 8, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00207350
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this
record on 2006-04-18