ParkinsonNCT05698784
123 I-FP-CIT SPECT Prescriptions for Parkinsonian Syndromes
An observational study of Parkinson, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson
- How many people
- 723 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Parkinsonian patients who benefited from a 123I-FP-CIT SPECT ,
Who may be able to join
- Parkinsonian patients who benefited from a 123I-FP-CIT SPECT
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relevance of 123 I-FP-CIT SPECT Prescriptions for the Diagnosis of 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.
Read the detailed description
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).
- Conditions
- Parkinson
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: February 2009 - May 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study startJun 2019
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 723 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de la Guadeloupe
- Responsible party
- Sponsor
- Investigators
- Bertrand DEGOS, MD, PhD, Study director, Hopital Avicenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698784
- Sponsor's protocol ID
- CLEA-2019-75
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of 123 I-FP-CIT SPECT Prescriptions for the Diagnosis of Parkinsonian Syndromes
- ClinicalTrials.gov ID
- NCT05698784
- Acronym / sponsor ID
- CLEA-2019-75
- Conditions
- Parkinson
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 723 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de la Guadeloupe
- Study start
- Jun 2019 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Parkinsonian patients who benefited from a 123I-FP-CIT SPECT ,
Key inclusion criteria (1 listed)
- Parkinsonian patients who benefited from a 123I-FP-CIT SPECT
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand DEGOS, MD, PhD study director
Hopital Avicenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the relevance of 123I-FP-CIT SPECT prescriptions (time frame: February 2009 - May 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.