Back to resultsCombined Role of Position Emission Tomography (PET) and Magnetoencephalography (MEG) in Nonlesional Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
magnetoencephalography
Positron emission tomography (PET)
Magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy focused on measuring epilepsy, pediatrics, magnetoencephalography, electroencephalography, positron emission tomography
Eligibility 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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
The concordance rate of FDG-PET and MEG with video EEG
Secondary Outcome Measures
The positive and negative predictive values of each modality and combined modalities in assessing the epileptogenic zone.
Full Information
NCT ID
NCT00741559
First Posted
August 25, 2008
Last Updated
May 12, 2014
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT00741559
Brief Title
Combined Role of Position Emission Tomography (PET) and Magnetoencephalography (MEG) in Nonlesional Epilepsy
Official Title
Combined Role of PET and MEG in Nonlesional Epilepsy in Pediatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, pediatrics, magnetoencephalography, electroencephalography, positron emission tomography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
magnetoencephalography
Intervention Description
MEG studies are performed using a whole-head Omega 151-channel gradiometer system.
Intervention Type
Device
Intervention Name(s)
Positron emission tomography (PET)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic resonance imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
The concordance rate of FDG-PET and MEG with video EEG
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The positive and negative predictive values of each modality and combined modalities in assessing the epileptogenic zone.
Time Frame
3 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Charron, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Combined Role of Position Emission Tomography (PET) and Magnetoencephalography (MEG) in Nonlesional Epilepsy
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