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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03100227
Acronym
BDD-FDG
Enrollment
41
Registered
2017-04-04
Start date
2014-09-15
Completion date
2017-07-06
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

OTHERPET [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.

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls.Day 140 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

MeasureTime frameDescription
Test-reliabilityWeek 2For 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026