UMIN-CTR Clinical Trial

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
Email	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
Email	ishii@pet.tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020572