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Completed

NCT Number: NCT03100227

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

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.

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET [18F] FDG

Other

Measurement of carbohydrate metabolism at the individual level. Standardization of the individual imaging data in a standard anatomical space and then calculation of an average image through the group-level controls.

Anatomical MRI

Other

All subjects will benefit from a 3D anatomical MRI to control the normality of their MRI and an automatic segmentation of 73 brain regions by multi-atlas segmentation.

Primary outcomes

  1. 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

  1. Test-reliability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: BDD-FDG

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Apr 4, 2017
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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