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Monitoring Neural Tissues Properties by Modulated Imaging (MI) (MI)

This study has been withdrawn prior to enrollment.
(no subject)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555711
First Posted: November 9, 2007
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose

We have developed a safe, non-contact, intra-operative guidance system to optimize tumor resection in neurosurgery. The Modulated Imaging is non-contact optical imaging technology developed at the Beckman Laser Institute, UCI.

Compared to other imaging approaches, MI has the unique capability of performing both diffuse optical tomography and rapid, wide-field quantitative mapping of tissue optical properties within a single measurement platform.

Preliminary in vivo studies have shown that brain tumors, infiltrating tumor margins and normal brain may have intrinsically different optical properties.


Condition Intervention
Brain Tumor Device: Modulated Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Monitoring Neural Tissues Properties by Modulated Imaging (MI)

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Brain Tissue Property [ Time Frame: 12 weeks ]

Enrollment: 0
Study Start Date: November 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Modulated Imaging
Modulated Imaging
Device: Modulated Imaging
Modulated Imaging

Detailed Description:

While compatible with time-modulation methods, MI alternatively uses spatially-modulated illumination for imaging of tissue constituents.

The Modulated Imaging system consists of

  1. a light projection system that illuminates the tissue with spatial sinusoid patterns.
  2. a CCD camera which collects the diffusely reflected light in a non-contact geometry. The wavelength of illumination can be selected by bandpass filtering of a broadband source,or by use of a monochromatic source.

Lastly, tissue fluorescence measurements can be performed by placing a combination of source-blocking and bandpass emission filters in front of the camera.

The diffusely reflected amplitude of the modulated wave carries both optical property (absorption, fluorescence, scattering) and depth information. Specifically, the sampling depth of the spatially-modulated wave is a function of the frequency of illumination and the tissue optical properties.

During neurosurgery when nervous tissue is exposed by the attending neurosurgeon, intraoperative pictures will be taken using the modulated imager by the investigators.

The imaging procedure may delay completion of the surgical case by an estimated 10 to 20 minutes. This is minimal prolongation considering most brain tumor resections take several hours.

The images acquired will be processed after the surgical procedure and will not be available to the surgeon during the operative procedure.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • All nervous system tumor patients who undergo a preoperative MRI,and undergoing central nervous system operative procedures for non tumor.

Exclusion Criteria:

  • All emergency neurosurgical procedures.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555711


Locations
United States, California
Beckman Laser Institute,University of California,Irvine
Irvine, California, United States, 92612
Neurosurgery department,University of California,Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Mark Linskey, MD Neurosurgery department,University of California,Irvine
Principal Investigator: Bruce J Tromberg, PhD Beckman Laser Institute University of California Irvine
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Mark Linskey, MD.,Department of Neurosurgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00555711     History of Changes
Other Study ID Numbers: NIH-LAMMP 2005-4775
First Submitted: November 7, 2007
First Posted: November 9, 2007
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
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