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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000016811 |
Receipt No. | R000019511 |
Scientific Title | Multi-center study of construction of normal database for 123I-ioflupane SPECT |
Date of disclosure of the study information | 2015/03/16 |
Last modified on | 2018/03/23 |
Basic information | ||
Public title | Multi-center study of construction of normal database for 123I-ioflupane SPECT | |
Acronym | normal database for 123I-ioflupane SPECT | |
Scientific Title | Multi-center study of construction of normal database for 123I-ioflupane SPECT | |
Scientific Title:Acronym | normal database for 123I-ioflupane SPECT | |
Region |
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Condition | ||
Condition | healthy volunteers | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Construction of normal database of dopamine transporter density using 123I-ioflupan SPECT in healthy volunteers |
Basic objectives2 | Others |
Basic objectives -Others | Correction of SPECT data between scanners |
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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) Japanese
(2) 30-90 years old (3) UPDRS Part III <5 (4)Beck Depression Inventory <10 (5)MOCA-J >=26 (6) Person with the ability to understand and obey the contents of a study (7)The person who can get consent by a document from the person himself |
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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) Unsuitable subject for this study judged by researchers |
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Target sample size | 240 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Center of Neurology and Psychiatry | ||||||
Division name | Integrative Brain Imaging Center | ||||||
Zip code | |||||||
Address | 4-1-1, Ogawahigashi, Kodaira, Tokyo, Japan | ||||||
TEL | 042-341-2711 | ||||||
matsudah@ncnp.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Center of Neurology and Psychiatry | ||||||
Division name | Integrative Brain Imaging Center | ||||||
Zip code | |||||||
Address | 4-1-1, Ogawahigashi, Kodaira, Tokyo, Japan | ||||||
TEL | 042-341-2711 | ||||||
Homepage URL | http://www.ncnp.go.jp/ibic/index.html | ||||||
matsudah@ncnp.go.jp |
Sponsor | |
Institute | National Center of Neurology and Psychiatry |
Institute | |
Department |
Funding Source | |
Organization | Nihon Medi-Physics |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Nakamura Memorial Hospital
Tohoku University Chiba University Nippon Medical School Showa University Fujita Health Univeristy Kobe University |
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 | 岩手医科大学(岩手県)
東北大学(宮城県) 千葉大学(千葉県) 国立精神・神経医療研究センター(東京都) 日本医科大学(東京都) 昭和大学(東京都) 藤田保健衛生大学(愛知県) 神戸大学(兵庫県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | https://link.springer.com/article/10.1007%2Fs00259-018-3976-5 |
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 | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019511 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |