Brain DiseasesATLATEPNCT05355857
Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.
A study testing brain PET-MRI with 18F-FDG in people with Brain Diseases, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Diseases
- What is being tested?
- brain PET-MRI with 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 10 Aug 2022to 23 Mar 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 20 to 50
- Absence of any history or cardiovascular, neurological or psychiatric deficit
- Signed the informed consent
Who cannot join
- Contraindication to the realization of an MRI or PET and to the injection of 18F-FDG
- People using a pacemaker or insulin pump
- People wearing a metal prosthesis or an intracerebral clip
- People with intraocular metal splinters
- People with a pathology considered incompatible for the production of the atlas according to the investigator
- Pregnant women and breastfeeding women
- Subject in period of exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. This type of atlas is essential for intra- and inter-individual comparisons.
Accurate quantitative analysis of brain 18F-FDG PET images acquired on a hybrid PET system has been shown to require an institutional normal database for statistical analyzes (Akdemir et al., JNM 2017 and Della Rosa et al Neuroinformatics, 2014).
Read the detailed description
This is a prospective, monocentric, non-randomized study, with no direct individual benefit since it involved healthy volunteers.
- Conditions
- Brain Diseases
- Being tested
- brain PET-MRI with 18F-FDG
- Keywords
- FDG PET, PET-MRI, atlas, brain
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brain PET-MRI with 18F-FDGDiagnostic test
Realisation of a brain PET-MRI with 18F-FDG in 39 healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG injection | Other | Health volunteers with 18-F-FDG injection Receives: Diagnostic Test: brain PET-MRI with 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers
Evaluation of tracer activity at the cerebral level on the acquisition images
Measured: 30 minutes after 18F-FDG injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start10 Aug 2022
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Healthy volunteers
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Collaborators
- ICube Laboratory
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355857
- Sponsor's protocol ID
- 2021-008
- Acronym
- ATLATEP
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.
- ClinicalTrials.gov ID
- NCT05355857
- Acronym / sponsor ID
- ATLATEP / 2021-008
- Conditions
- Brain Diseases
- Keywords
- FDG PET, PET-MRI, atlas, brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Collaborators
- ICube Laboratory
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 2 May 2022 (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.
With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. This type of atlas is essential for intra- and inter-individual comparisons.
Accurate quantitative analysis of brain 18F-FDG PET images acquired on a hybrid PET system has been shown to require an institutional normal database for statistical analyzes (Akdemir et al., JNM 2017 and Della Rosa et al Neuroinformatics, 2014).
Detailed description
This is a prospective, monocentric, non-randomized study, with no direct individual benefit since it involved healthy volunteers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG injection | Other | Diagnostic Test: brain PET-MRI with 18F-FDGHealth volunteers with 18-F-FDG injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 20 to 50
- Absence of any history or cardiovascular, neurological or psychiatric deficit
- Signed the informed consent
Key exclusion criteria (7 listed)
- Contraindication to the realization of an MRI or PET and to the injection of 18F-FDG
- People using a pacemaker or insulin pump
- People wearing a metal prosthesis or an intracerebral clip
- People with intraocular metal splinters
- People with a pathology considered incompatible for the production of the atlas according to the investigator
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 |
|---|---|---|
| brain PET-MRI with 18F-FDGRealisation of a brain PET-MRI with 18F-FDG in 39 healthy volunteers | Diagnostic test | 18F-FDG injection |
Primary outcome
Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers
Time frame: 30 minutes after 18F-FDG injection
Evaluation of tracer activity at the cerebral level on the acquisition images
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 7 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brain PET-MRI with 18F-FDG in people with Brain Diseases, run by Institut de cancérologie Strasbourg Europe 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 7 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 7 Apr 2023. 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. 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?
Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers (time frame: 30 minutes after 18F-FDG injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2023.