UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007779 |
|---|---|
| Receipt number | R000009160 |
| Scientific Title | Evaluation of Brain Dopaminergic Function using 18F-FDOPA PET in Parkinson's Disease and Related Disorders |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2016/04/18 16:18:00 |
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Basic information
Public title
Evaluation of Brain Dopaminergic Function using 18F-FDOPA PET in Parkinson's Disease and Related Disorders
Acronym
18F-FDOPA PET in Parkinson's Disease and Related Disorders
Scientific Title
Evaluation of Brain Dopaminergic Function using 18F-FDOPA PET in Parkinson's Disease and Related Disorders
Scientific Title:Acronym
18F-FDOPA PET in Parkinson's Disease and Related Disorders
Region
| Japan |
Condition
Condition
Parkinson's disease and related disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the usefulness of 18F-FDOPA PET in the differential diagnosis of Parkinson's disease from other related disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
18F-FDOPA PET imaging
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
1. Patients with Parkinson's disease based on the UK Brain Bank criteria
2. Patients with Parkinson's disease related disorders which are difficult to differentiate them from Parkinson's disease
3. Patients whose dopaminergic therapy can be stopped before PET if they have already started dopamine replacement therapy
Key exclusion criteria
1. Patients who cannot stay rest on a scanner bed at least for 60 minutes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenao Fukuyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Brain Research Center
Zip code
Address
Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3695
fukuyama@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoya Oishi |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Brain Research Center
Zip code
Address
Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3695
Homepage URL
noishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Human Brain Research Center, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Takeda Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 06 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PET scanning using 18F-FDOPA takes place. Neurological examinations takes place within a month before, 6 and 12 months after PET.
Management information
Registered date
| 2012 | Year | 04 | Month | 17 | Day |
Last modified on
| 2016 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009160
