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Intraoperative Optical Imaging of Brain Function


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Trial Information

Intraoperative Optical Imaging of Brain Function


A speckle-contrast imaging camera uses a low-power laser to check brain activity. The
imaging camera uses reflected red light to take a special kind of picture of the amount of
blood flowing in your brain, and the amount of oxygen in your blood. This is the first time
this device has been used in brain surgery.

While "asleep" under anesthesia during an already scheduled surgery, the neurosurgeon will
position the microscope to take pictures of the surgery area. The pictures will be taken
after the brain is exposed, but before the rest of the surgery takes place. Researchers
will shine the red light onto the brain during your surgery. The light will then be seen by
the camera.

"Cortical mapping" will done, which is an established procedure used to detect important
areas of the brain. Usually, a nerve in the wrist is stimulated with a very small shock of
electricity and a response is detected in the brain by an electrode placed on the surface.
The electrical shock administered is not dangerous or painful. It will be given while
"asleep." For the experimental procedure used in this study, the same stimulation will be
used, but the impulse detection will be performed using the speckle-contrast imaging camera.
Researchers hope to see if the change in blood flow gives the same information as if the
electrode was placed on the brain and used to detect the electricity. Doing both procedures
is expected to take no more than 20 minutes. During this time, continual monitoring done by
the surgeon and operating room staff.

Your participation in this study will end when the surgery is finished.

The results of this study will not be used by the surgeon during your surgery or any future
treatments. These measurements are being done for research only and will not be used by the
surgeon to make any decisions about your surgery.

This is an investigational study. This device is investigational and has not been approved
by the Food and Drug Administration (FDA), but it has been declared safe by the National
Institutes of Health. Up to 10 patients will take part in the study. All will be enrolled
at M. D. Anderson.


Inclusion Criteria:



1. Location of planned resection near somatosensory cortex.

2. Planned intraoperative electrocortical mapping.

3. Able to render written informed consent.

Exclusion Criteria:

1. Patients with a hemiparesis graded 3/5 (active movement against gravity) or worse.
Unpublished data from MDACC Department of Neurosurgery suggests that cortical mapping
is ineffective in these patients because an adequate cortical response is not
detected

2. Patients with a vascular malformation within the proximity of the cortex area imaged.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Test performance of novel optical imaging system for real-time quantitative imaging of brain function through multiple hemodynamic measures during neurosurgery

Outcome Time Frame:

2 Years

Safety Issue:

No

Principal Investigator

Jeffrey Weinberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0102

NCT ID:

NCT00632437

Start Date:

February 2008

Completion Date:

June 2010

Related Keywords:

  • Brain Tumor
  • Brain Tumor
  • Craniotomy Surgery
  • Brain Function
  • Intraoperative Optical Imaging
  • Speckle-Contrast Imaging
  • Cortical Mapping
  • Somatosensory Cortex
  • Cerebral blood flow
  • CBF
  • Laser Speckle Contrast Imaging
  • Multi-Spectral Imaging
  • Brain Neoplasms

Name

Location

U.T.M.D. Anderson Cancer Center Houston, Texas  77030