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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741559
First Posted: August 26, 2008
Last Update Posted: May 13, 2014
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.
Information provided by (Responsible Party):
Amer Shammas, The Hospital for Sick Children
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Combined Role of PET and MEG in Nonlesional Epilepsy in Pediatric Population

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The concordance rate of FDG-PET and MEG with video EEG [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • The positive and negative predictive values of each modality and combined modalities in assessing the epileptogenic zone. [ Time Frame: 3 years ]

Enrollment: 59
Study Start Date: March 2008
Study Completion Date: June 2011
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

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): NCT00741559


Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Martin Charron, MD The Hospital for Sick Children
  More Information

Responsible Party: Amer Shammas, Nuclear Medicine Radiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00741559     History of Changes
Other Study ID Numbers: 1000011429
First Submitted: August 25, 2008
First Posted: August 26, 2008
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by Amer Shammas, 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