Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
18 Years
N/A
Both
Brain Tumor
Trial Information
Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
PRIMARY OBJECTIVES:
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.
Inclusion Criteria:
- Neurosurgical patient population in the City of Hope brain and spinal tumor
neurosurgical programs that have been diagnosed with a brain tumor.
- Only lucid patients qualified to consent to neurosurgical procedure will be
approached for participation in this study.
- We do intend to enroll subjects with potentially terminal brain tumors. Due to the
potential benefit of intraoperative mapping, we are not planning to exclude these
subjects.
- Patients with any type of brain tumor will be eligible for participation.
- All subjects must have the ability to understand and the willingness to sign a
written informed consent.
Exclusion Criteria:
- There are no exclusion criteria except for individuals without a brain tumor and the
location of the craniotomy. If the exposed area of brain is not compatible with
peripheral stimuli or volitional activity the subject cannot be enrolled.
- Subjects, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy.
Outcome Description:
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.
Outcome Time Frame:
Day 1 post surgery
Safety Issue:
No
Principal Investigator
Neal Prakash, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Institutional Review Board
Study ID:
11320
NCT ID:
NCT01627535
Start Date:
May 2013
Completion Date:
Related Keywords:
- Brain Tumor
- Brain Tumor
- Brain Neoplasms
Name | Location |
|---|---|
| City of Hope Medical Center | Duarte, California 91010 |
