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Combined Role of Position Emission Tomography (PET) and Magnetoencephalography (MEG) in Nonlesional Epilepsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00741559
First received: August 25, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

The first aim of this study are to evaluate the lobar concordance of FDG-PET and MEG with intracranial electrographic study in children with intractable partial epilepsy. The second aim is to determine if the combined role of FDG-PET and MEG improve detection of epileptogenic zone as defined by invasive intracranial recordings.


Condition Intervention Phase
Epilepsy
 Device: magnetoencephalography
Device: Positron emission tomography (PET)
Device: Magnetic resonance imaging
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Combined Role of PET and MEG in Nonlesional Epilepsy in Pediatric Population

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy MRI Scans
U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • The concordance rate of FDG-PET and MEG with video EEG [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The positive and negative predictive values of each modality and combined modalities in assessing the epileptogenic zone. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 59
Study Start Date: March 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: magnetoencephalography
MEG studies are performed using a whole-head Omega 151-channel gradiometer system.
Device: Positron emission tomography (PET)
An interictal FDG(fluoro-D-glucose)-PET will be obtained in a single 10 minute scanning session. PET scans will be obtained using a 3D acquisition technique, which will allow the use of a lower dose of radiotracer.
Device: Magnetic resonance imaging
MR will be performed on a 1.5T or 3T system, using a combination of different sequences including sagittal T1, coronal and axial T2, FLAIR and proton density and axial 3D T1 weighted images.

Detailed Description:

Children with poorly controlled epilepsy are extensively investigated with various tools including MR brain, electroencephalography (EEG), magnetoencephalography (MEG) or position emission tomography (PET) scans. When MR brain does not show an abnormality, the patient is said to have nonlesional epilepsy. In these cases, it is even more crucial to be able to identify the epileptogenic zone, depending on availability of investigative tool.

Recognizing that individual modalities have limitations, the aim of this study is to determine if combining non-invasive investigations with MEG and PET, which respectively evaluate the electrical and metabolic activity of the brain, could improve the children with intractable nonlesional epilepsy with MEG and PET and compared this with invasive intracranial monitoring. The endpoint of the study being agreement on localizations of epileptogenic zone using PET and MEG individually and in combination and comparing this with invasive intracranial monitoring.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children between the ages 0-18 years with (1) nonlesional intractable focal epilepsy and (2) those with discordant clinical and EEG findings, who are potential surgical candidates

Exclusion Criteria:

  • Patients who are pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741559

Contacts
Contact: Martin Charron, MD (416)813-2006 martin.charron@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Martin Charron, MD     (416)813-2006     martin.charron@sickkids.ca    
Principal Investigator: Martin Charron, MD            
Sub-Investigator: Elysa Widjaja, MD            
Sub-Investigator: Charles Raybaud, MD            
Sub-Investigator: Carter Snead, MD            
Sub-Investigator: Hiroshi Otsubo, MD            
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Martin Charron, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Martin Charron/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00741559     History of Changes
Other Study ID Numbers: 1000011429
Study First Received: August 25, 2008
Last Updated: August 25, 2008
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
epilepsy
pediatrics
magnetoencephalography
electroencephalography
positron emission tomography

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013