Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2014 by City of Hope Medical Center
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01627535
First received: June 20, 2012
Last updated: December 19, 2014
Last verified: December 2014
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Purpose
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 | 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: | 10 |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627535
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: | December 19, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by City of Hope Medical Center:
|
Brain Tumor |
Additional relevant MeSH terms:
|
Brain Neoplasms Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms |
Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms |
ClinicalTrials.gov processed this record on March 01, 2015