UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028183 |
|---|---|
| Receipt number | 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 | 2020/01/12 09:43:41 |
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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 | Atsutaka |
| Middle name | |
| Last name | Okizaki |
Organization
Asahikawa Medical University
Division name
Department of Radiology
Zip code
078-8510
Address
2-1-1-1, Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2572
okizaki@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsutaka |
| Middle name | |
| Last name | Okizaki |
Organization
Asahikawa Medical University
Division name
Department of Radiology
Zip code
078-8510
Address
2-1-1-1, Midorigaokahigashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2572
Homepage URL
okizaki@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
Asahikawa Medical University
Address
2-1-1-1, Midorigaokahigashi, Asahikawa, Hokkaido, Japan
Tel
0166-68-2572
okizaki@asahikawa-med.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
| 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 01 | Day |
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
| 2020 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032266
| 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 |
