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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-15

Study Completion Date

2017-07-06

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

PET [18F] FDG

Intervention Type 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

Intervention Type 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.

Review test-retest

Of the 40 volunteers included, 10 will have test-retest exams (2 separate exams every 15 days).

Group Type SHAM_COMPARATOR

PET [18F] FDG

Intervention Type 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

Intervention Type 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.

Interventions

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PET [18F] FDG

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.

Intervention Type OTHER

Anatomical MRI

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes