Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

NCT ID: NCT01627535

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Brain Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optical Imaging

Patients undergo i2DOS

Group Type EXPERIMENTAL

Interoperative Optical Imaging and Spectroscopy

Intervention Type OTHER

Real time processing and display of i2DOS maps in the operating arena

Interventions

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Interoperative Optical Imaging and Spectroscopy

Real time processing and display of i2DOS maps in the operating arena

Intervention Type OTHER

Eligibility Criteria

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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

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal Prakash, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2012-01074

Identifier Type: REGISTRY

Identifier Source: secondary_id

11320

Identifier Type: -

Identifier Source: org_study_id

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