Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

NCT01627535 | Completed DMC

• 2 other identifiers: 11320NCI-2012-01074
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

Brain Tumor

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1 post surgery

• 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.

  Day 1 post surgery

Study Arms (1)

Optical Imaging

EXPERIMENTAL

Patients undergo i2DOS

Other: Interoperative Optical Imaging and Spectroscopy

Interventions

Interoperative Optical Imaging and Spectroscopy OTHER

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

Optical Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Spectrum Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Neal Prakash, MD, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 25, 2012
• Study Start: May 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)