(18)F-FDG PET Database of Adult Healthy Individuals

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: PET [18F] FDG; Other: Anatomical MRI

• Registration Number: NCT03100227
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-15
• Primary Completion: 2015-09-16
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Status Verified: 2017-07
• Study Completion: 2017-07-06
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PET [18F] FDG	Anatomical MRI	Each subject will have a PET scan at \[18F\] FDG.The raw imaging data obtained from these controls will be post-processed using the Statistical Parametric Mapping software. Schematically, the data of each control will be normalized in the same anatomical space, then smoothed and averaged between the different controls. This will make it possible to constitute the normative database.
Review test-retest	Anatomical MRI	Of the 40 volunteers included, 10 will have test-retest exams (2 separate exams every 15 days).
PET [18F] FDG	PET [18F] FDG	Each subject will have a PET scan at \[18F\] FDG.The raw imaging data obtained from these controls will be post-processed using the Statistical Parametric Mapping software. Schematically, the data of each control will be normalized in the same anatomical space, then smoothed and averaged between the different controls. This will make it possible to constitute the normative database.
Review test-retest	PET [18F] FDG	Of the 40 volunteers included, 10 will have test-retest exams (2 separate exams every 15 days).

Primary Outcome Measures

Name	Time	Method
Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls.	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 Outcome Measures

Name	Time	Method
Test-reliability	Week 2	For each subject, we will measure Glucose Metabolism of the whole brain estimated with \[18F\]-FDG PET for the first PET scan and for the second PET scan and evaluate the potential difference of Glucose Metabolism between the two scans.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France