Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

Brain Tumor Clinical Trial

Official title:

Feasibility of Intraoperative Optical Imaging and Spectroscopy in Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627535
• Other study ID #: 11320
• Secondary ID: NCI-2012-01074
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: January 19, 2016
• Start date: May 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Other:
• Interoperative Optical Imaging and Spectroscopy
Real time processing and display of i2DOS maps in the operating arena

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No