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

NCT00741559 | Completed Phase 3

• 1 other identifier: 1000011429
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

epilepsy; pediatrics; magnetoencephalography; electroencephalography; positron emission tomography

Outcome Measures

Primary Outcomes (1)

• The concordance rate of FDG-PET and MEG with video EEG

  3 years

Secondary Outcomes (1)

• The positive and negative predictive values of each modality and combined modalities in assessing the epileptogenic zone.

  3 years

Study Arms (1)

1

EXPERIMENTAL

Device: magnetoencephalography; Device: Positron emission tomography (PET); Device: Magnetic resonance imaging

Interventions

magnetoencephalography DEVICE

MEG studies are performed using a whole-head Omega 151-channel gradiometer system.

1

Positron emission tomography (PET) DEVICE

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.

1

Magnetic resonance imaging DEVICE

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.

1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients who are pregnant

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Magnetoencephalography; Positron-Emission Tomography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Martin Charron, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nuclear Medicine Radiologist

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

CA (1)