NCT05698784

Brief Summary

123I-FP-CIT SPECT (DaTSCAN®) allows to detect presynaptic dopamine neuronal denervation. It is recommended to differentiate neurodegenerative parkinsonism from secondary parkinsonian syndromes or from essential tremor, and to distinguish patients with suspected dementia with Lewy bodies and those with other subtypes of dementia. The aim of this retrospective study was to evaluate the relevance of 123I-FP-CIT SPECT prescriptions, the profile of prescribers and the evolution of the prescription rate over a ten-year period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
723

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration 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

Study Start

First participant enrolled

June 1, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

2.5 years

First QC Date

January 16, 2023

Last Update Submit

February 1, 2023

Conditions

Parkinson

Outcome Measures

Primary Outcomes (1)

  • Evaluate the relevance of 123I-FP-CIT SPECT prescriptions

    Regarding the relevance of the indications, we have defined three groups: " inappropriate ", "uncertain " and " relevant ", also respectively named (a), (b) and (c) groups. To identify which groups differed from each other, post hoc comparisons were made using the Tukey test for numeric variables and the Fisher pairwise exact test followed by the Benjamini-Hochberg correction to account for multiple testing, for categorical variables. For all tests.

    February 2009 - May 2019

Study Arms (3)

Group a "inappropriate"

In the "inappropriate" , we placed prescriptions with no indication, 123I-FP-CIT SPECT

Group b "uncertain"

In the "uncertain", we did not have sufficient data to determine with certainty whether this was an inappropriate or relevant indication.

Group c "relevant"

In the "relevant" , the prescriptions concerned the differential diagnosis between neurodegenerative parkinsonism and secondary parkinsonian syndromes

Eligibility Criteria

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

Adult Parkinsonian patients who benefited from a 123I-FP-CIT SPECT ,

You may qualify if:

  • Parkinsonian patients who benefited from a 123I-FP-CIT SPECT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Avicenne

Bobigny, 93000, France

Location

Study Officials

  • Bertrand DEGOS, MD, PhD

    Hopital Avicenne

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 26, 2023

Study Start

June 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 3, 2023

Record last verified: 2023-01

Locations

FR(1)