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

Civil Hospices of Lyon

Status: Completed

Conditions: Healthy

Treatments: Other: Anatomical MRI; Other: PET [18F] FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT03100227

69HCL16_0689

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

PET [18F] FDG

Active Comparator group

Description:

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.

Treatment:

Other: PET [18F] FDG

Other: Anatomical MRI

Review test-retest

Sham Comparator group

Description:

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

Treatment:

Other: PET [18F] FDG

Other: Anatomical MRI