UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017763 |
|---|---|
| Receipt number | R000020572 |
| Scientific Title | Comparison of striatal accumulation of dopamine transporter ligands with PET and SPECT |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2021/09/08 11:20:27 |
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Basic information
Public title
Comparison of striatal accumulation of dopamine transporter ligands with PET and SPECT
Acronym
Comparison of PET and SPECT dopamine transporter imaging
Scientific Title
Comparison of striatal accumulation of dopamine transporter ligands with PET and SPECT
Scientific Title:Acronym
Comparison of PET and SPECT dopamine transporter imaging
Region
| Japan |
Condition
Condition
Parkinson syndrome and healthy volunteer
Classification by specialty
| Neurology | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the bindings of 123I-ioflupane and 11C-PE2I in the striatum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the bindings of 123I-ioflupane and 11C-PE2I in the striatum in healthy control and Parkinson syndrome
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The subjects who have intention to participate in this study, and signed informed consent.
2. Male and female subjects of >=20 years, old.
3. The subjects who were diagnosed with Parkinson syndrome or healthy adult
Key exclusion criteria
1. The subjects with a history of brain diseases, excluding than cerebellar diseases.
2. The subjects who are prescribed a medication for the central nervous system.
3. The subject who have chronic dysfunction in the organs.
4. Pregnant or woman who has a chance of pregnant.
5. The subjects who were judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ishii |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
1730015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
ishii@pet.tmig.or.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ishii |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
1730015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
ishii@pet.tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Nihon Medi-Physics Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board, Tokyo Metropolitan Geriatric Center
Address
35-2 Sakaecho, Itabashi-ku, Tokyo
Tel
03-3964-3241
chiken@tmghig.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
地方独立行政法人東京都健康長寿医療センター研究所
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 01 | 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 | 04 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
We studied 12 cases of Parkinson's disease or related disorders with [123I]FP-CIT SPECT and [11C]CFT/[11C]PI2I PET. A head-to-head comparison of regional uptake of the tracers in the subregions of striatum appeared to be well correlated (R2 > 0.88). Quantitative evaluation of striatal pre-synaptic dopaminergic function with [123I]FP-CIT SPECT is considered to be a reliable method.
Management information
Registered date
| 2015 | Year | 06 | Month | 01 | Day |
Last modified on
| 2021 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020572
