UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study to evaluate the ability to differentiate Parkinson's disease and Parkinson's syndrome in patients having dopamine transporter scintigraphy.
Acronym	A retrospective study to evaluate the ability to differentiate Parkinson's disease and Parkinson's syndrome in patients having dopamine transporter scintigraphy.
Scientific Title	A retrospective study to evaluate the ability to differentiate Parkinson's disease and Parkinson's syndrome in patients having dopamine transporter scintigraphy.
Scientific Title:Acronym	A retrospective study to evaluate the ability to differentiate Parkinson's disease and Parkinson's syndrome in patients having dopamine transporter scintigraphy.
Region	Japan

Condition
Condition	Parkinson's disease and Parkinson's syndrome
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the ability to differentiate Parkinson's disease from Parkinson's syndrome by stratifying the degree of accumulation of Ioflupane in the brainstem in patients having dopamine transporter scintigraphy with Ioflupane.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	This is a descriptive study without a specific hypothesis and no statistical hypothesis testing will be performed. Based on the stratified test results and diagnoses, likelihood ratios to the disease diagnosis will be calculated and ROC curves will be generated. Thereby, the possibility of differentiation will be examined.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent dopamine transporter scintigraphy in our Neurology Department between July 1, 2014 and September 30, 2017. Patients who meet all of the following criteria will be included. Patients with Parkinsonism who have undergone dopamine transporter scintigraphy in the Department of Neurology of this hospital. The diagnosis can be confirmed 4 years after the dopamine transporter scintigraphy. All necessary data collection items are recorded in the electronic medical record.
Key exclusion criteria	Patients without parkinsonism. Patients with cerebrovascular or drug-induced parkinsonism.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Hamada
Organization	Kagawa University
Division name	Department of supportive and promotive medicine of the municipal hospital, Faculty of Medicine
Zip code	761-0693
Address	1750-1 Ikenobe, Miki, Kagawa 761-0793, Japan
TEL	087-891-2156
Email	hamada.yasuhiro@kagawa-u.ac.jp

Public contact
Name of contact person	1st name Yasuhiro Middle name Last name Hamada
Organization	Kagawa University
Division name	Department of supportive and promotive medicine of the municipal hospital, Faculty of Medicine
Zip code	761-0693
Address	1750-1 Ikenobe, Miki, Kagawa 761-0793, Japan
TEL	087-891-2156
Homepage URL
Email	hamada.yasuhiro@kagawa-u.ac.jp

Sponsor
Institute	Kagawa University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee, Faculty of Medicine, Kagawa University
Address	1750-1 Ikenobe, Miki, Kagawa 761-0793, Japan
Tel	087-891-2011
Email	kenkyushien@kagawa-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	51
Results	The degree of accumulation of Ioflupane in midbrain and pons was stratified into two groups: those with a similar degree of accumulation compared to that in the cerebellum, and those with a higher degree of accumulation than in the cerebellum. The midbrain was highly enriched in all patients with both Parkinson's disease (PD) and Parkinson's syndrome (PS). In pons, both PD and PS tended to be hyper-accumulated. Therefore, PD and PS were similar, and it was impossible to distinguish between them.
Results date posted	2022 Year 12 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2021 Year 11 Month 05 Day
Date of IRB	2021 Year 11 Month 05 Day
Anticipated trial start date	2021 Year 11 Month 05 Day
Last follow-up date	2022 Year 03 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Dopamine transporter scintigraphy images were visually evaluated. The degree of accumulation in the brainstem (midbrain and pons) was stratified into two groups: those with a similar degree of accumulation compared to that in the cerebellum, and those with a higher degree of accumulation than in the cerebellum. The study was terminated before reaching the target number of patients because it proved difficult to distinguish Parkinson's disease and Parkinson's syndrome by the degree of brainstem accumulation in dopamine transporter scintigraphy.

Management information
Registered date	2022 Year 12 Month 07 Day
Last modified on	2022 Year 12 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056627