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

NCT03100227 | Completed

• 1 other identifier: 69HCL16_0689
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

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.

  Day 1

Secondary Outcomes (1)

• Test-reliability

  Week 2

Study Arms (2)

PET [18F] FDG

ACTIVE COMPARATOR

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

Review test-retest

SHAM COMPARATOR

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

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.

PET [18F] FDG; Review test-retest

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.

PET [18F] FDG; Review test-retest

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Contraindication to the MRI
• Known neurological disease
• Adult subject to legal protection measure.
• Women of childbearing age who do not have effective contraception

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

Related Publications (2)

• 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.

  PMID: 40187100 BACKGROUND

• 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.

  PMID: 34529159 BACKGROUND

MeSH Terms

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Julien JUNG, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: April 4, 2017
• Study Start: September 15, 2014
• Primary Completion: September 16, 2015
• Study Completion: July 6, 2017
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)