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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05683665
Other study ID # 2022PI098
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date July 1, 2023

Study information

Verified date July 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date July 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Patients with Parkinson syndroma - Patients with Datscan in Nancy hospital bewteen septemnre 2019 and december 2022 Exclusion Criteria: - Patient with a known allergy to any of the components of DaTSCAN™. - Patient deprived of liberty by a judicial or administrative decision

Study Design


Related Conditions & MeSH terms


Intervention

Device:
scintigraphy DaTSCAN
DaTSCAN™ (123I-ioflupnae) tomoscintigraphy assesses the density of dopamine transporters (DATs) on the pre-synaptic membrane of dopaminergic neurons

Locations

Country Name City State
France CHRU Nancy Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year
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