Patients With Alzheimer's DiseasePET-SFNCT04718207
Modelling in the Quantitative Analysis of Brain PET Scans in Patients With Alzheimer's Disease
An observational study of Patients With Alzheimer's Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Alzheimer's Disease
- What is being tested?
- Brain positron emission tomopgraphy (PET) - scan
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2021to 1 Feb 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Alzheimer disease
Who may be able to join
- Brain PET/CT scans at 18F-FDG of patients with Alzheimer's disease carried out in the nuclear medicine department of the Nancy-Brabois University Hospital since December 2017 on digital PET devices.
Who cannot join
- Patients who have expressed their opposition to the use of their data (poster in the service).
Trial locations and contacts
1 site in 1 country.
France1 site
Nuclear medicine department CHRU de NANCY Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Interest of PFS Modelling in the Quantitative Analysis of Brain PET Scans in Patients With Alzheimer's Disease Acquired on a Numerical System
PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. To complete the diagnosis, a semi-quantitative analysis of the images is recommended (European recommendations) in addition to the visual analysis.
Read the detailed description
PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. To complete the diagnosis, a semi-quantitative analysis of the images is recommended (European recommendations) in addition to the visual analysis.
PET technology is improving from year to year thanks to the arrival of a new PET technology called digital. In addition, correction methods have been developed to improve PET images and thus improve the detection of different pathologies in PET.
The PSF (Point Spread Function) tool enables partial volume effects to be corrected. The PSF consists of correcting the impulse response of the system, and allows a visual improvement of the images. Currently not recommended in brain PET/CT reconstructions, it remains to be evaluated for the quantitative analysis of acquisitions.
- Conditions
- Patients With Alzheimer's Disease
- Being tested
- Brain positron emission tomopgraphy (PET) - scan
- Keywords
- Alzheimer disease, PSF modelisation, quantitative analyze
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain positron emission tomopgraphy (PET) - scanDevice
Patients who performed brain PET/CT scans in the nuclear medicine department from December 2017 to December 2020.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Alzheimer disease | Patients recruited retrospectively with the available nuclear medicine listing of patients who performed brain PET/CT scans in the nuclear medicine department from December 2017 to December 2020. Receives: Device: Brain positron emission tomopgraphy (PET) - scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The results obtained in quantitative analysis with and without PSF modelling of PET brain scans of patients with Alzheimer's disease acquired on PET / CT scan
Comparison of the volumes detected by the quantitative analysis with the SPM (statistical parametric Mapping) software of brain PET scans of patients with Alzheimer's disease with and without FSP modelling.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Aug 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine VERGER, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718207
- Sponsor's protocol ID
- S201215_051
- Acronym
- PET-SF
- Status last verified
- Aug 2022
- First submitted
- 18 Jan 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of PFS Modelling in the Quantitative Analysis of Brain PET Scans in Patients With Alzheimer's Disease Acquired on a Numerical System
- ClinicalTrials.gov ID
- NCT04718207
- Acronym / sponsor ID
- PET-SF / S201215_051
- Conditions
- Patients With Alzheimer's Disease
- Keywords
- Alzheimer disease, PSF modelisation, quantitative analyze
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 22 Jan 2021 (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.
PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. To complete the diagnosis, a semi-quantitative analysis of the images is recommended (European recommendations) in addition to the visual analysis.
Detailed description
PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. To complete the diagnosis, a semi-quantitative analysis of the images is recommended (European recommendations) in addition to the visual analysis.
PET technology is improving from year to year thanks to the arrival of a new PET technology called digital. In addition, correction methods have been developed to improve PET images and thus improve the detection of different pathologies in PET.
The PSF (Point Spread Function) tool enables partial volume effects to be corrected. The PSF consists of correcting the impulse response of the system, and allows a visual improvement of the images. Currently not recommended in brain PET/CT reconstructions, it remains to be evaluated for the quantitative analysis of acquisitions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Alzheimer disease | – | Device: Brain positron emission tomopgraphy (PET) - scanPatients recruited retrospectively with the available nuclear medicine listing of patients who performed brain PET/CT scans in the nuclear medicine department from December 2017 to December 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Alzheimer disease
Key inclusion criteria (1 listed)
- Brain PET/CT scans at 18F-FDG of patients with Alzheimer's disease carried out in the nuclear medicine department of the Nancy-Brabois University Hospital since December 2017 on digital PET devices.
Key exclusion criteria (1 listed)
- Patients who have expressed their opposition to the use of their data (poster in the service).
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 positron emission tomopgraphy (PET) - scanPatients who performed brain PET/CT scans in the nuclear medicine department from December 2017 to December 2020. | Device | Patient with Alzheimer disease |
Primary outcome
The results obtained in quantitative analysis with and without PSF modelling of PET brain scans of patients with Alzheimer's disease acquired on PET / CT scan
Time frame: 6 months
Comparison of the volumes detected by the quantitative analysis with the SPM (statistical parametric Mapping) software of brain PET scans of patients with Alzheimer's disease with and without FSP modelling.
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 24 Aug 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of Patients With Alzheimer's Disease, run by Central Hospital, Nancy, France 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 1 inclusion and 1 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 24 Aug 2022. 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?
The results obtained in quantitative analysis with and without PSF modelling of PET brain scans of patients with Alzheimer's disease acquired on PET / CT scan (time frame: 6 months). 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 24 Aug 2022.