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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028183
Receipt No. R000032266
Scientific Title A study of 123I-ioflupan SPECT in normal adult subjects.
Date of disclosure of the study information 2017/07/12
Last modified on 2017/07/11

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Basic information
Public title A study of 123I-ioflupan SPECT in normal adult subjects.
Acronym A study of 123I-ioflupan SPECT in normal adult subjects.
Scientific Title A study of 123I-ioflupan SPECT in normal adult subjects.
Scientific Title:Acronym A study of 123I-ioflupan SPECT in normal adult subjects.
Region
Japan

Condition
Condition Normal adult subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of normal range in normal adult subjects with 123I-ioflupan SPECT
Basic objectives2 Others
Basic objectives -Others Evaluation of normal range
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Specific binding of 123I-ioflupan to dopamine transporter in striatum
Key secondary outcomes

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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Administration of radiopharmaceutical
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
90 years-old >=
Gender Male and Female
Key inclusion criteria (1) Japanese
(2) 30-90 years old
(3) UPDRS Part III <5
(4)MOCA-J >=26
(5) Person with the ability to understand and obey the contents of a study
(6)The person who can get consent by a document from the person himself
Key exclusion criteria (1) Neurological abnormality
(2) Dementia by DSM V
(3) Family history for Parkisonism or DLB
(4) Contraindication for MRI
(5) Taking medicine that influence on accumulation of 123I-ioflupan in the brain
(6) REM sleep behavior disorder
(7) Allergy for alcohol or iodide
(8) Pregnant woman, lactating woman and person with a pregnant possibility
(9) Liver dysfunction
(10) Unsuitable subject for this study judged by researchers
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsutaka Okizaki
Organization Asahikawa Medical University
Division name Department of Radiology
Zip code
Address 2-1-1-1, Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2572
Email okizaki@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsutaka Okizaki
Organization Asahikawa Medical University
Division name Department of Radiology
Zip code
Address 2-1-1-1, Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2572
Homepage URL
Email okizaki@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Japan society for the Promotion of Science
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
2017 Year 07 Month 12 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 11 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032266

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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