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Completed

NCT Number: NCT05698784

123 I-FP-CIT SPECT Prescriptions for Parkinsonian Syndromes

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Avicenne

Bobigny, 93000, France

About this study

the investigators included 723 patients in this retrospective study between February 2009 and May 2019, in the nuclear medicine Department of Avicenne University Hospital. No patients were excluded. Demographic, clinical, brain imaging, and 123I-FP-CIT SPECT data were collected from medical records. The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Ethics Committee (CLEA-2019-75).

Regarding the relevance of the indications, the investigators have defined three groups: " inappropriate ", "uncertain " and " relevant ", also respectively named (a), (b) and (c) groups.

In the "inappropriate" group (a), the investigators placed prescriptions with no indication, 123I-FP-CIT SPECT requested to confirm a PS clinically evident, and those prescribed for isolated cognitive-behavioral disturbances with no PS or differential diagnosis mentioned.

In the "uncertain" group (b), the investigators did not have sufficient data to determine with certainty whether this was an inappropriate or relevant indication.

In the "relevant" group (c), the prescriptions concerned the differential diagnosis between neurodegenerative parkinsonism and secondary parkinsonian syndromes (for instance post-neuroleptics) or other doubtful disorders (Alzheimer's disease, essential tremor), clinically uncertain PS (such as an isolated asymmetric resting tremor without akinesia or lead-pipe rigidity) and PD of atypical evolution.

Data were presented as mean (standard deviation) for numeric variables and as count (percentage) for categorical variables. To compare demographic, clinical and paraclinical data, and the distribution of prescribers between the three groups (i.e. inappropriate (a), uncertain (b) and relevant (c)), one-factor analysis of variance (ANOVA) was used for numerical variables and Fisher's exact test for categorical variables. 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, the significance level was set at p < 0.05. All data were analyzed using R software (version 3.6.1, R Core Team).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary outcomes

  1. Evaluate the relevance of 123I-FP-CIT SPECT prescriptions

    Time frame: February 2009 - May 2019

    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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Centre Hospitalier Universitaire de la Guadeloupe

Registry information

Official study title

Relevance of 123 I-FP-CIT SPECT Prescriptions for the Diagnosis of Parkinsonian Syndromes

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2023
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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