Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

Not Applicable

Completed

• Conditions: Brain Tumor
• Interventions: Other: Interoperative Optical Imaging and Spectroscopy

• Registration Number: NCT01627535
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-25
• Study Start: 2013-05
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optical Imaging	Interoperative Optical Imaging and Spectroscopy	Patients undergo i2DOS

Primary Outcome Measures

Name	Time	Method
Intraoperative determination of the location of critical brain functions.	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.
Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy.	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States