Neurodegenerative DiseasesBASITEPNCT04163276
Database of Positon Emission Tomography (PET) Digital Brain Exams, in 50th Age of Patients
An observational study of Neurodegenerative Diseases, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This study evaluate the interest to create a new database of PET digital brain exams in population of 50 years and over of patients. Half of patients with no abnormal brain metabolism while the other half patients with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- 18F FDG PET exam
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2008to Oct 2020
- 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
- Adult, Older adult
Study population: The population will be enrolled thank to a listing of patient available in nuclear médicine unit. This listing cntain patient who performed a 18F-FDG brain TEP in nuclear médicine unit between 2010 and 2019.
Who may be able to join
- Having performed a 18F-FDG cerebral PET/CT exam as part of an Alzheimer's assessment at the Nuclear Medicine department of NANCY, sent by the Geriatric Department
- Patient who has received complete information on the organization of the research and who has not objected to the exploitation of this data
- Patient affiliated to a social security
Who cannot join
- patient who has received complete information on the organization of the research and who has objected to the exploitation of this data
- For patients with no abnormality in 18F-FDG PET, Mini Mental State Examination (MMSE) <25 or clinically diagnosed neurodegenerative pathology
- For patients with typical hypometabolism of 18F-FDG PET/CT, biology of cerebrospinal fluid not in favor of Alzheimer's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creation of a Database of PET Digital Brain Exams, Adapted to a Population Aged 50 Years and Over, to Help in the Interpretation of Fluoro Desoxy Glucose (FDG) Labelled With Fluor 18 (18F-FDG) PET/CT (Computer Tomography) Exam
This study evaluate the interest to create a new database of PET digital brain exams in population of 50 years and over of patients. Half of patients with no abnormal brain metabolism while the other half patients with Alzheimer's disease.
Read the detailed description
The 18F-FDG cerebral PET can be performed for the detection of neurodegenerative diseases found hypometabolism in the areas concerned (Alzheimer's disease, fronto-temporal dementia, dementia Lewy body etc). The diagnosis is given by the clinician with a visual analysis of the data. Technical aids are now recommended (European recommendations) to complete the diagnosis with a quantitative analysis of different brain regions to a healthy brain base, to guide the diagnosis, in addition to visual analysis.
The emergence of a new technology has allowed the transition from analog PET / CT to digital PET / CT improving spatial resolution and image contrast. Unlike analog PET / CT that uses photomultipliers to detect light, digital PET / CT uses the digital photon counting technique to directly convert light into a digital signal and each crystal is connected to a single detector.
Different software, used in clinical routine, gives access to a quantified analysis of different areas of the brain. However, these programs have been made with healthy subjects of reduced strength (for example, the Neuro Q ® software database is based on 29 healthy patients), with no specific age and thanks to analog PET / CT ( old generation). There is therefore a low specificity in terms of detection of degenerative pathologies, this being explained by a decrease in cerebral metabolism with age 9, mainly at the level of the anterior areas 10 (frontal lobe, temporopolar areas, insular areas, cortex anterior cingulate).
- Conditions
- Neurodegenerative Diseases
- Being tested
- 18F FDG PET exam
- Keywords
- neurodegenerative disease, digital brain PET exam, database
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F FDG PET examDiagnostic test
All patients have received 18F-FDG PET/CT in nuclear medicine
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 20 patients without anomaly of brain metabolism Receives: Diagnostic Test: 18F FDG PET exam | |
| Group 2 | 20 patients with Alzheimer's disease Receives: Diagnostic Test: 18F FDG PET exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
data base analysis
Comparison of Z-scores from PET/CT of the quantitative analysis of patients without abnormality of the brain metabolism and of typical Alzheimer patients (brain metabolism of the regions involved in Alzheimer's disease), calculated with 2 databases:
- An analogue database consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over;
- A digital database, consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start2 Jan 2008
- Primary completion6 Jun 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- GIE NANCYCLOTEP
- Responsible party
- Sponsor
- Investigators
- Verger Antoine, PhD, Study chair, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163276
- Sponsor's protocol ID
- 2019PI238
- Acronym
- BASITEP
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2019
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Database of PET Digital Brain Exams, Adapted to a Population Aged 50 Years and Over, to Help in the Interpretation of Fluoro Desoxy Glucose (FDG) Labelled With Fluor 18 (18F-FDG) PET/CT (Computer Tomography) Exam
- ClinicalTrials.gov ID
- NCT04163276
- Acronym / sponsor ID
- BASITEP / 2019PI238
- Conditions
- Neurodegenerative Diseases
- Keywords
- neurodegenerative disease, digital brain PET exam, database
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- GIE NANCYCLOTEP
- Study start
- 2 Jan 2008 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 14 Nov 2019 (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.
This study evaluate the interest to create a new database of PET digital brain exams in population of 50 years and over of patients. Half of patients with no abnormal brain metabolism while the other half patients with Alzheimer's disease.
Detailed description
The 18F-FDG cerebral PET can be performed for the detection of neurodegenerative diseases found hypometabolism in the areas concerned (Alzheimer's disease, fronto-temporal dementia, dementia Lewy body etc). The diagnosis is given by the clinician with a visual analysis of the data. Technical aids are now recommended (European recommendations) to complete the diagnosis with a quantitative analysis of different brain regions to a healthy brain base, to guide the diagnosis, in addition to visual analysis.
The emergence of a new technology has allowed the transition from analog PET / CT to digital PET / CT improving spatial resolution and image contrast. Unlike analog PET / CT that uses photomultipliers to detect light, digital PET / CT uses the digital photon counting technique to directly convert light into a digital signal and each crystal is connected to a single detector.
Different software, used in clinical routine, gives access to a quantified analysis of different areas of the brain. However, these programs have been made with healthy subjects of reduced strength (for example, the Neuro Q ® software database is based on 29 healthy patients), with no specific age and thanks to analog PET / CT ( old generation). There is therefore a low specificity in terms of detection of degenerative pathologies, this being explained by a decrease in cerebral metabolism with age 9, mainly at the level of the anterior areas 10 (frontal lobe, temporopolar areas, insular areas, cortex anterior cingulate).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: 18F FDG PET exam20 patients without anomaly of brain metabolism |
| Group 2 | – | Diagnostic Test: 18F FDG PET exam20 patients with Alzheimer's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The population will be enrolled thank to a listing of patient available in nuclear médicine unit. This listing cntain patient who performed a 18F-FDG brain TEP in nuclear médicine unit between 2010 and 2019.
Key inclusion criteria (3 listed)
- Having performed a 18F-FDG cerebral PET/CT exam as part of an Alzheimer's assessment at the Nuclear Medicine department of NANCY, sent by the Geriatric Department
- Patient who has received complete information on the organization of the research and who has not objected to the exploitation of this data
- Patient affiliated to a social security
Key exclusion criteria (3 listed)
- patient who has received complete information on the organization of the research and who has objected to the exploitation of this data
- For patients with no abnormality in 18F-FDG PET, Mini Mental State Examination (MMSE) <25 or clinically diagnosed neurodegenerative pathology
- For patients with typical hypometabolism of 18F-FDG PET/CT, biology of cerebrospinal fluid not in favor of Alzheimer's disease
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 |
|---|---|---|
| 18F FDG PET examAll patients have received 18F-FDG PET/CT in nuclear medicine | Diagnostic test | Group 1, Group 2 |
Primary outcome
data base analysis
Time frame: 1 hour
Comparison of Z-scores from PET/CT of the quantitative analysis of patients without abnormality of the brain metabolism and of typical Alzheimer patients (brain metabolism of the regions involved in Alzheimer's disease), calculated with 2 databases: * An analogue database consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over; * A digital database, consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over
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 27 Nov 2020.
- 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.
Verger Antoine, PhD study chair
Central Hospital, Nancy, France
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 Neurodegenerative Diseases, 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 3 inclusion and 3 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 27 Nov 2020. 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?
data base analysis (time frame: 1 hour). 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 27 Nov 2020.