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Clinical Trials/NCT03100227
NCT03100227
Completed
Not Applicable

(18)F-FDG PET Database of Adult Healthy Individuals for Clinical Studies in Epileptic Patients

Hospices Civils de Lyon1 site in 1 country41 target enrollmentSeptember 15, 2014
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Hospices Civils de Lyon
Enrollment
41
Locations
1
Primary Endpoint
Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls.
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide.

Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Focal Hypometabolism on interictal [18F]-FDG PET is a hallmark of the Seizure Onset Zone as well as surrounding areas. Using [18F]-FDG PET is thus particularly useful to determine the seizure onset zone of epileptic patients and thus to guide surgical treatment when antiepileptic drugs fail.

Interpretation of PET images primarily relies on standard visual analysis, but statistical analysis, with the widely used Statistical Parametric Mapping (SPM) software improves the diagnostic yield of PET. Over the past years, some authors have thus reported that the use of SPM can result in greater sensitivity and specificity of PET imaging in patients with partial epilepsy.

In order to perform statistical analysis of PET images to compare brain metabolism of epileptic patients and healthy controls, it is necessary to collect a normative database of [18F]-FDG PET images in healthy controls.

The purpose of this study is (i) collect a normative database of [18F]-FDG PET images in healthy adults controls to evaluate rigorously the diagnostic value of multimodal imaging for non-invasive localization of the EZ and (ii) to evaluate the test-retest reliability of [18F]-FDG PET scanning.

Registry
clinicaltrials.gov
Start Date
September 15, 2014
End Date
July 6, 2017
Last Updated
7 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • healthy adult controls
  • Age 20-65 years
  • Signed informed consent form.

Exclusion Criteria

  • Contraindication to the MRI
  • Known neurological disease
  • Adult subject to legal protection measure.
  • Women of childbearing age who do not have effective contraception

Outcomes

Primary Outcomes

Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls.

Time Frame: Day 1

40 healthy controls (age range 20-65 years) will undergo \[18F\]-FDG PET. The Glucose Metabolism for whole brain will be determined with \[18F\]-FDG PET for each subject.

Secondary Outcomes

  • Test-reliability(Week 2)

Study Sites (1)

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