Monitoring Neural Tissues Properties by Modulated Imaging (MI)

Brain Tumor Clinical Trial

— MI  

Official title:

Monitoring Neural Tissues Properties by Modulated Imaging (MI)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00555711
• Other study ID #: 20054775
• Status: Withdrawn
• Start date: November 2008
• Est. completion date: January 2012

Study information

• Verified date: October 2022
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

Device:
• Modulated Imaging
Modulated Imaging

Locations

Country	Name	City	State
United States	Beckman Laser Institute,University of California,Irvine	Irvine	California
United States	Neurosurgery department,University of California,Irvine	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Beckman Laser Institute University of California Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Tissue Property		12 weeks