UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019255 |
|---|---|
| Receipt number | R000022264 |
| Scientific Title | Evaluation study of the utility of imaging diagnostic method for dopamine transporter function |
| Date of disclosure of the study information | 2015/10/08 |
| Last modified on | 2019/12/19 17:17:39 |
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Basic information
Public title
Evaluation study of the utility of imaging diagnostic method for dopamine transporter function
Acronym
DAT Scan PE2I study
Scientific Title
Evaluation study of the utility of imaging diagnostic method for dopamine transporter function
Scientific Title:Acronym
DAT Scan PE2I study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the correlation of dopamine transporter functional assessment by various imaging methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the results of dopamine transporter PET and SPECT
Key secondary outcomes
Comparison of the results of dopamine transporter PET and neuromelanin MRI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
PET by [18F] FE-PE2I, SPECT by [123I] FP-CIT, neuromelanin MRI
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who have the ability to provide informed consent and adhere to the protocol.
Normal controls:
- Without subjective cognitive impairment
- Without past or current history of cognitive dysfunction
- Without past or current history of disease and injury that influences the central nervous system
- Without past history of smoking
- Without taking psychotropic drug
Key exclusion criteria
- With past or current history of serious medical illness
- With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- Subjects who has possibility of pregnancy or is breast-feeding
- Subjects who has been exposed to radiation by job-related exposure or therapy in one year exceeding 15mSv
- Subjects who received contrast or radioactive agent within two days of the examination.
- Subjects who scheduled receiving contrast or radioactive agent the day after the examination.
- Subjects who are judged as not suitable for participation in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Okubo |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-Ku, Tokyo
TEL
03-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | Amane |
| Middle name | |
| Last name | Tateno |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-Ku, Tokyo
TEL
03-3822-2131
Homepage URL
amtateno@nms.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital Institutional Review Board
Address
1-1-5, Sendagi, Bunkyo-Ku, Tokyo, Japan
Tel
+81-3-3822-2131
clinicaltrial@nms.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
| 2015 | Year | 10 | Month | 08 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022264
