HealthyBDD-FDGNCT03100227
(18)F-FDG PET Database of Adult Healthy Individuals
A study testing PET [18F] FDG and Anatomical MRI in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PET [18F] FDG and Anatomical MRI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2014to 6 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adult controls
- Age 20-65 years
- Signed informed consent form.
Who cannot join
- Contraindication to the MRI
- Known neurological disease
- Adult subject to legal protection measure.
- Women of childbearing age who do not have effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (18)F-FDG PET Database of Adult Healthy Individuals for Clinical Studies in Epileptic Patients
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.
Read more
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
- Being tested
- PET [18F] FDG, Anatomical MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET [18F] FDGOther
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 MRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: PET [18F] FDG; Other: Anatomical MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start15 Sep 2014
- Primary completion16 Sep 2015
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien JUNG, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100227
- Sponsor's protocol ID
- 69HCL16_0689
- Acronym
- BDD-FDG
- Status last verified
- Sep 2025
- First submitted
- 23 Feb 2017
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 40187100Merida 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (18)F-FDG PET Database of Adult Healthy Individuals for Clinical Studies in Epileptic Patients
- ClinicalTrials.gov ID
- NCT03100227
- Acronym / sponsor ID
- BDD-FDG / 69HCL16_0689
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 16 Sep 2015 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET [18F] FDG | Active comparator | Other: PET [18F] FDG, Other: Anatomical MRIEach 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. |
| Review test-retest | Sham comparator | Other: PET [18F] FDG, Other: Anatomical MRIOf the 40 volunteers included, 10 will have test-retest exams (2 separate exams every 15 days). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy adult controls
- Age 20-65 years
- Signed informed consent form.
Key exclusion criteria (4 listed)
- Contraindication to the MRI
- Known neurological disease
- Adult subject to legal protection measure.
- Women of childbearing age who do not have effective contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET [18F] FDGMeasurement 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. | Other | PET [18F] FDG, Review test-retest |
| Anatomical MRIAll 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. | Other | PET [18F] FDG, Review test-retest |
Primary outcome
Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls.
Time frame: Day 1
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.
1 secondary outcome
Test-reliability
Time frame: Week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 40187100Zotova 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.
- Results publication: PubMed 34529159Merida 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien JUNG, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET [18F] FDG and Anatomical MRI in people with Healthy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Metabolism of the whole brain estimated with [18F]-FDG PET in healthy controls. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03100227, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.