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

Healthy Clinical Trial

— BDD-FDG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100227
• Other study ID #: 69HCL16_0689
• Status: Completed
• Phase: N/A
• First received: February 23, 2017
• Last updated: July 6, 2017
• Start date: September 15, 2014
• Est. completion date: July 6, 2017

Study information

• Verified date: July 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 6, 2017
• Est. primary completion date: September 16, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 2