Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01627535
First received: June 20, 2012
Last updated: May 13, 2014
Last verified: May 2014

June 20, 2012
May 13, 2014
May 2013
June 2017   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01627535 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain Tumor
Other: Interoperative Optical Imaging and Spectroscopy
Real time processing and display of i2DOS maps in the operating arena
Experimental: Optical Imaging
Patients undergo i2DOS
Intervention: Other: Interoperative Optical Imaging and Spectroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
June 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
United States
 
NCT01627535
11320, NCI-2012-01074
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Neal Prakash, MD, PhD City of Hope Medical Center
City of Hope Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP