UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017168 |
|---|---|
| Receipt number | R000019916 |
| Scientific Title | Assessment of diagnostic accuracy of dopamine receptor imaging agent "Ioflupane" for the patients with parkinsonism |
| Date of disclosure of the study information | 2015/04/20 |
| Last modified on | 2019/04/24 17:53:20 |
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Basic information
Public title
Assessment of diagnostic accuracy of dopamine receptor imaging agent "Ioflupane" for the patients with parkinsonism
Acronym
Diagnostic accuracy of Ioflupane
Scientific Title
Assessment of diagnostic accuracy of dopamine receptor imaging agent "Ioflupane" for the patients with parkinsonism
Scientific Title:Acronym
Diagnostic accuracy of Ioflupane
Region
| Japan |
Condition
Condition
Parkinsonism
Classification by specialty
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the current study is to investigate the diagnostic accuracy of Ioflupane for the several diseases with parkinsonism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of each disease with parkinsonism
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Satisfying the following 2 conditions within 3 months.
1)Undergoing physical, laboratory and neuropsychological examinations by neurologist.
2)Undergoing Ioflupane imaging.
Key exclusion criteria
In case of declaration of non-participation.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Anri |
| Middle name | |
| Last name | Inaki |
Organization
Kanazawa University Hospital
Division name
Department of Nuclear Medicine
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa
TEL
076-265-2333
henri@nmd.m.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Anri |
| Middle name | |
| Last name | Inaki |
Organization
Kanazawa University Hospital
Division name
Department of Nuclear Medicine
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa
TEL
076-265-2333
Homepage URL
henri@nmd.m.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University
Address
13-1, Takara-machi, Kanazawa
Tel
076-265-2090
crc.irb-knz@esct.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
| 2015 | Year | 04 | Month | 20 | 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
Results
Results date posted
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2015 | Year | 04 | Month | 18 | Day |
Last modified on
| 2019 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019916
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
