Parkinson DiseaseDAPSYFIXNCT05683665
DaTSCAN Brain Scintigraphy and Psychotropic Treatments: Influence on Radiotracer Binding
An observational study of Parkinson Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
DaTSCAN™ (123I-ioflupnae) tomoscintigraphy assesses the density of dopamine transporters (DATs) on the presynaptic membrane of dopaminergic neurons. This examination is used in clinical routine in patients presenting a parkinsonian syndrome in search of a pre-synaptic dopaminergic denervation pointing to a… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- scintigraphy DaTSCAN
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2023to 1 Jul 2023
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: All patients routinely referred for SPECT examination assessing the pre-synaptic dopaminergic pathway
Who may be able to join
- Patients with Parkinson syndroma
- Patients with Datscan in Nancy hospital bewteen septemnre 2019 and december 2022
Who cannot join
- Patient with a known allergy to any of the components of DaTSCAN™.
- Patient deprived of liberty by a judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
DaTSCAN™ (123I-ioflupnae) tomoscintigraphy assesses the density of dopamine transporters (DATs) on the presynaptic membrane of dopaminergic neurons. This examination is used in clinical routine in patients presenting a parkinsonian syndrome in search of a pre-synaptic dopaminergic denervation pointing to a neurodegenerative origin of this syndrome To date, there is little literature data evaluating the influence of psychotropic treatments frequently used in clinical routine on DaTSCAN™ CT images. Some studies have shown that SSRI (selective serotonin reuptake inhibitor) and SNRI (serotonin and norepinephrine reuptake inhibitor) antidepressants can significantly alter striatal ioflupane uptake ratios (10-20%) with no obvious influence on the visual interpretation of the examination .
The objective of this study was to evaluate the influence of the most commonly used psychotropic therapies, sometimes in combination, on DaTSCAN™ CT images with a large population of patients included in clinical routine.
Read the detailed description
DaTSCAN™ (123I-ioflupnae) tomoscintigraphy assesses the density of dopamine transporters (DATs) on the presynaptic membrane of dopaminergic neurons. This examination is used in clinical routine in patients presenting a parkinsonian syndrome in search of a pre-synaptic dopaminergic denervation pointing to a neurodegenerative origin of this syndrome Some drugs, and in particular psychotropic treatments, have an ability to bind to dopamine transporters or to mobilize endogenous dopamine and may thus interfere with ioflupane binding. Visual interpretation of the DaTSCAN™ scan as well as semi-quantitative analysis (radiotracer binding ratios) takes into account striatal binding activity and also activity in the rest of the brain parenchyma (background) . Therefore, drugs that interfere with striatal or extra-striatal binding of ioflupane may have an impact on the examination result.
To date, there is little literature data evaluating the influence of psychotropic treatments frequently used in clinical routine on DaTSCAN™ CT images. Some studies have shown that SSRI (selective serotonin reuptake inhibitor) and SNRI (serotonin and norepinephrine reuptake inhibitor) antidepressants can significantly alter striatal ioflupane uptake ratios (10-20%) with no obvious influence on the visual interpretation of the examination . Antipsychotic and antiparkinsonian drugs appear to have no effect on ioflupane uptake and should not be discontinued before the examination is performed. Finally, lithium treatment could significantly reduce ioflupane binding.
The majority of studies analyzing the effects of medication on ioflupane binding have been conducted in small numbers or assess the potential impact of therapy on a theoretical basis.
The objective of this study was to evaluate the influence of the most commonly used psychotropic therapies, sometimes in combination, on DaTSCAN™ CT images with a large population of patients included in clinical routine.
- Conditions
- Parkinson Disease
- Being tested
- scintigraphy DaTSCAN
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scintigraphy DaTSCANDevice
DaTSCAN™ (123I-ioflupnae) tomoscintigraphy assesses the density of dopamine transporters (DATs) on the pre-synaptic membrane of dopaminergic neurons
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of psychotropic treatments on radiotracer uptake during DaTSCAN™ tomoscintigraphies.
Binding ratios (specific binding ratio) stratum/occipital cortex, caudate nucleus/occipital cortex, putamen/occipital cortex on the left and right and total number of strokes recorded as a function of the presence or absence of psychotropic treatment at the time of examination
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Apr 2023
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- 300 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
- NCT05683665
- Sponsor's protocol ID
- 2022PI098
- Acronym
- DAPSYFIX
- Status last verified
- Jul 2023
- First submitted
- 5 Jan 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DaTSCAN Brain Scintigraphy and Psychotropic Treatments: Influence on Radiotracer Binding
- ClinicalTrials.gov ID
- NCT05683665
- Acronym / sponsor ID
- DAPSYFIX / 2022PI098
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 13 Jan 2023 (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.
DaTSCAN™ (123I-ioflupnae) tomoscintigraphy assesses the density of dopamine transporters (DATs) on the presynaptic membrane of dopaminergic neurons. This examination is used in clinical routine in patients presenting a parkinsonian syndrome in search of a pre-synaptic dopaminergic denervation pointing to a neurodegenerative origin of this syndrome To date, there is little literature data evaluating the influence of psychotropic treatments frequently used in clinical routine on DaTSCAN™ CT images. Some studies have shown that SSRI (selective serotonin reuptake inhibitor) and SNRI (serotonin and norepinephrine reuptake inhibitor) antidepressants can significantly alter striatal ioflupane uptake ratios (10-20%) with no obvious influence on the visual interpretation of the examination .
The objective of this study was to evaluate the influence of the most commonly used psychotropic therapies, sometimes in combination, on DaTSCAN™ CT images with a large population of patients included in clinical routine.
Detailed description
DaTSCAN™ (123I-ioflupnae) tomoscintigraphy assesses the density of dopamine transporters (DATs) on the presynaptic membrane of dopaminergic neurons. This examination is used in clinical routine in patients presenting a parkinsonian syndrome in search of a pre-synaptic dopaminergic denervation pointing to a neurodegenerative origin of this syndrome Some drugs, and in particular psychotropic treatments, have an ability to bind to dopamine transporters or to mobilize endogenous dopamine and may thus interfere with ioflupane binding. Visual interpretation of the DaTSCAN™ scan as well as semi-quantitative analysis (radiotracer binding ratios) takes into account striatal binding activity and also activity in the rest of the brain parenchyma (background) . Therefore, drugs that interfere with striatal or extra-striatal binding of ioflupane may have an impact on the examination result.
To date, there is little literature data evaluating the influence of psychotropic treatments frequently used in clinical routine on DaTSCAN™ CT images. Some studies have shown that SSRI (selective serotonin reuptake inhibitor) and SNRI (serotonin and norepinephrine reuptake inhibitor) antidepressants can significantly alter striatal ioflupane uptake ratios (10-20%) with no obvious influence on the visual interpretation of the examination . Antipsychotic and antiparkinsonian drugs appear to have no effect on ioflupane uptake and should not be discontinued before the examination is performed. Finally, lithium treatment could significantly reduce ioflupane binding.
The majority of studies analyzing the effects of medication on ioflupane binding have been conducted in small numbers or assess the potential impact of therapy on a theoretical basis.
The objective of this study was to evaluate the influence of the most commonly used psychotropic therapies, sometimes in combination, on DaTSCAN™ CT images with a large population of patients included in clinical routine.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients routinely referred for SPECT examination assessing the pre-synaptic dopaminergic pathway
Key inclusion criteria (2 listed)
- Patients with Parkinson syndroma
- Patients with Datscan in Nancy hospital bewteen septemnre 2019 and december 2022
Key exclusion criteria (2 listed)
- Patient with a known allergy to any of the components of DaTSCAN™.
- Patient deprived of liberty by a judicial or administrative decision
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 |
|---|---|---|
| scintigraphy DaTSCANDaTSCAN™ (123I-ioflupnae) tomoscintigraphy assesses the density of dopamine transporters (DATs) on the pre-synaptic membrane of dopaminergic neurons | Device | – |
Primary outcome
The influence of psychotropic treatments on radiotracer uptake during DaTSCAN™ tomoscintigraphies.
Time frame: 1 year
Binding ratios (specific binding ratio) stratum/occipital cortex, caudate nucleus/occipital cortex, putamen/occipital cortex on the left and right and total number of strokes recorded as a function of the presence or absence of psychotropic treatment at the time of examination
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 6 Jul 2023.
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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 Parkinson 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 2 inclusion and 2 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 6 Jul 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?
The influence of psychotropic treatments on radiotracer uptake during DaTSCAN™ tomoscintigraphies. (time frame: 1 year). 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 6 Jul 2023.