Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00632437 |
The goal of this proposal is to test the performance of a novel optical imaging system for real-time quantitative imaging of brain function through multiple hemodynamic measures during neurosurgery.
This pilot study encompasses two sub-aims:
Condition | Intervention |
---|---|
Brain Tumor |
Procedure: Speckle-Contrast Imaging |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Intraoperative Optical Imaging of Brain Function |
Estimated Enrollment: | 10 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
Speckle-Contrast Imaging
|
Procedure: Speckle-Contrast Imaging
Imaging camera scan that uses reflected red light to take pictures of the amount of blood flowing in brain and the amount of oxygen in blood.
|
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.
If you are found to be eligible to take part in this study, while you are "asleep" under anesthesia during your 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 your brain during your surgery. The light will then be seen by the camera.
You will also have "Cortical mapping", 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 you are "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, you will be continually watched 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients having a brain tumor which is scheduled to be surgically removed.
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey Weinberg, MD | 713-792-2400 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Jeffrey Weinberg, MD |
Principal Investigator: | Jeffrey Weinberg, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Jeffrey Weinberg, MD/Associate Professor ) |
Study ID Numbers: | 2006-0102 |
Study First Received: | February 13, 2008 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00632437 History of Changes |
Health Authority: | United States: Institutional Review Board |
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 Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
Brain Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases |
Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |