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123 I-FP-CIT SPECT Prescriptions for Parkinsonian Syndromes

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT05698784
Collaborator
Centre Hospitalier Universitaire de Pointe-a-Pitre (Other)
723
Enrollment
1
Location
30
Actual Duration (Months)
24.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    We 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, we have defined three groups: " inappropriate ", "uncertain " and " relevant ", also respectively named (a), (b) and (c) groups.

    In the "inappropriate" group (a), we 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), we 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).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    723 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Relevance of 123 I-FP-CIT SPECT Prescriptions for the Diagnosis of Parkinsonian Syndromes
    Actual Study Start Date :
    Jun 1, 2019
    Actual Primary Completion Date :
    Dec 1, 2021
    Actual Study Completion Date :
    Dec 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Parkinsonian patients who benefited from a 123I-FP-CIT SPECT
    Exclusion criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Avicenne Bobigny France 93000

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris
    • Centre Hospitalier Universitaire de Pointe-a-Pitre

    Investigators

    • Study Director: Bertrand DEGOS, MD, PhD, Hopital Avicenne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT05698784
    Other Study ID Numbers:
    • CLEA-2019-75
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinsonian Disorders

    Study Results

    No Results Posted as of Jan 26, 2023