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Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01627535
Enrollment
4
Registered
2012-06-25
Start date
2013-05-31
Completion date
2016-01-31
Last updated
2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor

Keywords

Brain Tumor

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.

Interventions

OTHERInteroperative Optical Imaging and Spectroscopy

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
City of Hope Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy.Day 1 post surgeryOptical 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.Day 1 post surgeryWe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026