DAPSYFIX: DaTSCAN Brain Scintigraphy and Psychotropic Treatments: Influence on Radiotracer Binding

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05683665

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

37.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: scintigraphy DaTSCAN

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

DaTSCAN Brain Scintigraphy and Psychotropic Treatments: Influence on Radiotracer Binding

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

The influence of psychotropic treatments on radiotracer uptake during DaTSCAN™ tomoscintigraphies. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU Nancy	Vandœuvre-lès-Nancy		France	54511

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antoine VERGER, MD, PhD, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT05683665

Other Study ID Numbers:

2022PI098

First Posted:

Jan 13, 2023

Last Update Posted:

Jan 13, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jan 13, 2023