NCT00632437

Brief Summary

The goal of this proposal is to test the performance of a novel optical imaging system for real-time quantitative imaging of brain function through multiple hemodynamic measures during neurosurgery. This pilot study encompasses two sub-aims:

  • Evaluate the ability of laser speckle contrast imaging to image cerebral blood flow (CBF) intraoperatively. We will image the changes in CBF in response to somatosensory stimulation. (5 patients).
  • Simultaneously image hemoglobin oxygenation, blood volume, blood flow, and cerebral metabolic rate of oxygen (CMRO2) changes during somatosensory stimulation using a combined laser speckle and multi-wavelength reflectance imaging system. (5 patients).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

February 13, 2008

Last Update Submit

July 27, 2012

Conditions

Keywords

Brain TumorCraniotomy SurgeryBrain FunctionIntraoperative Optical ImagingSpeckle-Contrast ImagingCortical MappingSomatosensory CortexCerebral blood flowCBFLaser Speckle Contrast ImagingMulti-Spectral Imaging

Outcome Measures

Primary Outcomes (1)

  • Test performance of novel optical imaging system for real-time quantitative imaging of brain function through multiple hemodynamic measures during neurosurgery

    2 Years

Study Arms (1)

Speckle-Contrast Imaging

Procedure: Speckle-Contrast Imaging

Interventions

Imaging camera scan that uses reflected red light to take pictures of the amount of blood flowing in brain and the amount of oxygen in blood.

Speckle-Contrast Imaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having a brain tumor which is scheduled to be surgically removed.

You may qualify if:

  • Location of planned resection near somatosensory cortex.
  • Planned intraoperative electrocortical mapping.
  • Able to render written informed consent.

You may not qualify if:

  • Patients with a hemiparesis graded 3/5 (active movement against gravity) or worse. Unpublished data from MDACC Department of Neurosurgery suggests that cortical mapping is ineffective in these patients because an adequate cortical response is not detected
  • Patients with a vascular malformation within the proximity of the cortex area imaged.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Jeffrey Weinberg, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2008

First Posted

March 10, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations