NCT00555711

Brief 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.

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 Nov 2008

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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withdrawn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

First Submitted

Initial submission to the registry

November 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

3.2 years

First QC Date

November 7, 2007

Last Update Submit

October 19, 2022

Conditions

Brain Tumor

Keywords

Brain tumor

Outcome Measures

Primary Outcomes (1)

  • Brain Tissue Property

    12 weeks

Study Arms (1)

Modulated Imaging

Modulated Imaging

Device: Modulated Imaging

Interventions

Modulated ImagingDEVICE

Modulated Imaging

Modulated Imaging

Eligibility Criteria

Age1 Minute+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

  • All emergency neurosurgical procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beckman Laser Institute,University of California,Irvine

Irvine, California, 92612, United States

Location

Neurosurgery department,University of California,Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mark Linskey, MD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

  • Bruce J Tromberg, PhD

    Beckman Laser Institute University of California Irvine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mark Linskey, MD.,Department of Neurosurgery

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 9, 2007

Study Start

November 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

US(2)