Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Brain Tumor	Other: Interoperative Optical Imaging and Spectroscopy	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	4 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
Study Start Date :	May 2013
Actual Primary Completion Date :	January 2016
Actual Study Completion Date :	January 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Optical Imaging; Patients undergo i2DOS	Other: Interoperative Optical Imaging and Spectroscopy; Real time processing and display of i2DOS maps in the operating arena

Outcome Measures

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Primary Outcome Measures :

1. Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy. [ Time Frame: 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.
2. Intraoperative determination of the location of critical brain functions. [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, California
City of Hope Medical Center
Duarte, California, United States, 91010

Sponsors and Collaborators

City of Hope Medical Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Neal Prakash, MD, PhD	City of Hope Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT01627535 History of Changes
Other Study ID Numbers:	11320; NCI-2012-01074 ( Registry Identifier: NCI CTRP )
First Posted:	June 25, 2012
Last Update Posted:	January 20, 2016
Last Verified:	January 2016

Keywords provided by City of Hope Medical Center:

Brain Tumor

Additional relevant MeSH terms:

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site	Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases