Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01627535|
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment|
|Brain Tumor||Other: Interoperative Optical Imaging and Spectroscopy|
I. To develop the instrumentation to achieve real time processing and display of intraoperative 2-dimensional optical imaging and spectroscopy (i2DOS) maps in the operating arena.
II. To examine the timing and spatial involvement of human cortex intraoperatively to different stimuli using i2DOS.
OUTLINE: Patients undergo i2DOS.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors|
|Study Start Date :||May 2013|
|Primary Completion Date :||January 2016|
|Study Completion Date :||January 2016|
Experimental: Optical Imaging
Patients undergo i2DOS
Other: Interoperative Optical Imaging and Spectroscopy
Real time processing and display of i2DOS maps in the operating arena
- Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy. [ Time Frame: Day 1 post surgery ]Optical reflectance images will be analyzed by pixel by-pixel subtraction of a control trial and a stimulation trial. This subtracted image will then be divided by the control image to normalize for differences between subjects and trials. These ratios thus represent proportional changes from baseline.
- Intraoperative determination of the location of critical brain functions. [ Time Frame: Day 1 post surgery ]We will examine the timing and spatial involvement of human cortex intraoperatively to different stimuli using i2DOS. Stimulus parameters will be varied to investigate stimulus-response relationships. We will study areas of sensori-motor and language cortex using customary stimuli for evoked potentials (i.e. transcutaneous electrical nerve stimulation), tactile stimuli for exposed cortical dermatome representations, and language tasks for cortical language representations. Results will be correlated with intraoperative electrophysiological measures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627535
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Neal Prakash, MD, PhD||City of Hope Medical Center|