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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019255
Receipt No. 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 2018/10/08

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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
Middle name
Last name Yoshiro Okubo, M.D., Ph.D.
Organization Nippon Medical School
Division name Department of Neuropsychiatry
Zip code
Address 1-1-5, Sendagi, Bunkyo-Ku, Tokyo
TEL 03-3822-2131
Email okubo-y@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Amane Tateno, M.D., Ph.D.
Organization Nippon Medical School
Division name Department of Neuropsychiatry
Zip code
Address 1-1-5, Sendagi, Bunkyo-Ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email amtateno@nms.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Nippon Medical School
Institute
Department

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
Address
Tel
Email

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
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
2018 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022264

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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