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Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

Primary Purpose

Brain Tumor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interoperative Optical Imaging and Spectroscopy
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optical Imaging

Arm Description

Patients undergo i2DOS

Outcomes

Primary Outcome Measures

Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2012
Last Updated
January 19, 2016
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01627535
Brief Title
Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
Official Title
Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial studies optical imaging in assessing activity during surgery in patients with brain tumors. New procedures, such as optical spectroscopy, may help doctors maximally remove brain tumors and minimize damage to normal brain.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
Brain Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optical Imaging
Arm Type
Experimental
Arm Description
Patients undergo i2DOS
Intervention Type
Other
Intervention Name(s)
Interoperative Optical Imaging and Spectroscopy
Intervention Description
Real time processing and display of i2DOS maps in the operating arena
Primary Outcome Measure Information:
Title
Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy.
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.
Time Frame
Day 1 post surgery
Title
Intraoperative determination of the location of critical brain functions.
Description
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.
Time Frame
Day 1 post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Prakash, MD, PhD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

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