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CompletedNCT03100227BDD-FDGUpdated Sep 15, 2025

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

An interventional study of PET [18F] FDG and Anatomical MRI in Healthy, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Sep 2014, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Active comparator
    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.

    Other: PET [18F] FDG · Other: Anatomical MRI

  • Sham comparator
    Review test-retest

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

    Other: PET [18F] FDG · Other: Anatomical MRI

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.

  • OtherAnatomical 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.

06

What researchers measure

Primary outcomes

  1. Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls.

    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.

    Time frame: Day 1

Secondary outcomes

  1. Test-reliability

    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.

    Time frame: Week 2

07

Study locations

1 site
  • Hospices Civils de Lyon
    Bron, 69500, France
08

References and documents

Publications

  • Zotova D, Pinon N, Trombetta R, Bouet R, Jung J, Lartizien C. GAN-based synthetic FDG PET images from T1 brain MRI can serve to improve performance of deep unsupervised anomaly detection models. Comput Methods Programs Biomed. 2025 Jun;265:108727. doi: 10.1016/j.cmpb.2025.108727. Epub 2025 Mar 31. PubMed 40187100 ↗
  • Merida I, Jung J, Bouvard S, Le Bars D, Lancelot S, Lavenne F, Bouillot C, Redoute J, Hammers A, Costes N. CERMEP-IDB-MRXFDG: a database of 37 normal adult human brain [18F]FDG PET, T1 and FLAIR MRI, and CT images available for research. EJNMMI Res. 2021 Sep 16;11(1):91. doi: 10.1186/s13550-021-00830-6. PubMed 34529159 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03100227
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Apr 4, 2017
Start date
Sep 15, 2014
Primary completion
Sep 16, 2015
Completion
Jul 6, 2017
Last update
Sep 15, 2025

Study contacts

Julien JUNG, MD
principal investigator · Hospices Civils de Lyon

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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