Trial record 20 of 380 for:    Open Studies | "Brain Neoplasms"

Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

This study is currently recruiting participants.
Verified November 2013 by City of Hope Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01627535
First received: June 20, 2012
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

This clinical trial studies optical imaging in assessing activity during surgery in patients with brain tumors. New diagnostic procedures, such as optical spectroscopy, may help doctors measure a patient's response during surgery


Condition Intervention
Brain Tumor
Other: Interoperative Optical Imaging and Spectroscopy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Determination of the effectiveness of intraoperative optical imaging technology and optical spectroscopy. [ Time Frame: Day 1 post surgery ] [ Designated as safety issue: No ]
    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.

  • Intraoperative determination of the location of critical brain functions. [ Time Frame: Day 1 post surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optical Imaging
Patients undergo i2DOS
Other: Interoperative Optical Imaging and Spectroscopy
Real time processing and display of i2DOS maps in the operating arena

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627535

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: City of Hope    800-826-4673      
Principal Investigator: Neal Prakash, MD, PhD         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Neal Prakash, MD, PhD City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01627535     History of Changes
Other Study ID Numbers: 11320, NCI-2012-01074
Study First Received: June 20, 2012
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014