NCT05683665

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

January 5, 2023

Last Update Submit

July 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients routinely referred for SPECT examination assessing the pre-synaptic dopaminergic pathway

You may qualify if:

  • Patients with Parkinson syndroma
  • Patients with Datscan in Nancy hospital bewteen septemnre 2019 and december 2022

You may not qualify if:

  • Patient with a known allergy to any of the components of DaTSCAN™.
  • Patient deprived of liberty by a judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations