Intraoperative Optical Imaging of Brain Function
| Tracking Information | |||||
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| First Received Date ICMJE | February 13, 2008 | ||||
| Last Updated Date | July 27, 2012 | ||||
| Start Date ICMJE | February 2008 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Test performance of novel optical imaging system for real-time quantitative imaging of brain function through multiple hemodynamic measures during neurosurgery [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The goal of this clinical research study is to test a new kind of scan called speckle-contrast imaging that may help researchers more easily find areas of the brain during surgery that control functions such as finger movement and feeling. [ Time Frame: 1 Year ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00632437 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intraoperative Optical Imaging of Brain Function | ||||
| Official Title ICMJE | Intraoperative Optical Imaging of Brain Function | ||||
| Brief Summary | 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:
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients having a brain tumor which is scheduled to be surgically removed. |
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| Condition ICMJE | Brain Tumor | ||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | Speckle-Contrast Imaging
Intervention: Procedure: Speckle-Contrast Imaging |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00632437 | ||||
| Other Study ID Numbers ICMJE | 2006-0102 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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