Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
This clinical trial studies optical imaging in assessing activity during surgery in patients with brain tumors. New diagnostic procedures, such as optical spectroscopy, may help doctors measure a patient's response during surgery
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors|
- Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy. [ Time Frame: Day 1 post surgery ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2013|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Experimental: Optical Imaging
Patients undergo i2DOS
Other: Interoperative Optical Imaging and Spectroscopy
Real time processing and display of i2DOS maps in the operating arena
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627535
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: City of Hope 800-826-4673|
|Principal Investigator: Neal Prakash, MD, PhD|
|Principal Investigator:||Neal Prakash, MD, PhD||City of Hope Medical Center|