NCT00001554

Brief Summary

It is extremely important to identify and distinguish healthy brain tissue from diseased brain tissue during neurosurgery. If normal tissue is damaged during neurosurgery it can result in long term neurological problems for the patient. The brain tissue as it appears prior to the operation on CT scan and MRI is occasionally very different from how it appears during the actual operation. Therefore, it is necessary to develop diagnostic procedures that can be used during the operation Presently, the techniques used for intraoperative mapping of the brain are not reliable in all cases in which they are used. Researchers in this study have developed a new approach that may allow diseased brain tissue to be located during an operation with little risk. This new approach uses nfrared technology to locate the diseased tissue and identify healthy brain tissue. The goal of this study is to investigate the clinical use of intraoperative infrared (IR) neuroimaging to locate diseased tissue and distinguish it from normal functioning tissue during the operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 1996

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Cortical LocalizationOptical ImagingThermal Imaging

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Adult patients who will be undergoing craniotomy for lesions such as tumor, epileptic focus, vascular malformation or infection. Adult patients who are able to provide informed consent.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Brugge JF, Poon PW, So AT, Wu BM, Chan FH, Lam FK. Thermal images of somatic sensory cortex obtained through the skull of rat and gerbil. Exp Brain Res. 1995;106(1):7-18. doi: 10.1007/BF00241352.

    PMID: 8542979BACKGROUND
  • George JS, Lewine JD, Goggin AS, Dyer RB, Flynn ER. IR thermal imaging of a monkey's head: local temperature changes in response to somatosensory stimulation. Adv Exp Med Biol. 1993;333:125-36. doi: 10.1007/978-1-4899-2468-1_12. No abstract available.

    PMID: 8362657BACKGROUND

MeSH Terms

Conditions

EpilepsyNeurologic Manifestations

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

June 1, 1996

Study Completion

June 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-05

Locations