UMIN-CTR Clinical Trial

Basic information
Public title	Bindings of 11C-ITMM in patients with cerebellar diseases
Acronym	Bindings of 11C-ITMM in patients with cerebellar diseases
Scientific Title	Bindings of 11C-ITMM in patients with cerebellar diseases
Scientific Title:Acronym	Bindings of 11C-ITMM in patients with cerebellar diseases
Region	Japan

Condition
Condition	cerebellar diseases
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Investigating the bindings of 11C-ITMM in the cerebellum
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between the bindings of 11C-ITMM and the degree of severity in cerebellar diseases
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	90 years-old >
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 and <90 years, old. 3. The subjects who were diagnosed with cerebellar diseases
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 Ishibashi
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Zip code	113-0015
Address	35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Email	ishibashi@pet.tmig.or.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Ishibashi
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Zip code	113-0015
Address	35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Homepage URL
Email	ishibashi@pet.tmig.or.jp

Sponsor
Institute	Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology
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	IRB at Tokyo Metropolitan Institute of Gerontology
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel	03-3964-3241
Email	sato@pet.tmig.or.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	2014 Year 11 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	10
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	2014 Year 09 Month 01 Day
Date of IRB	2014 Year 09 Month 05 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	non

Management information
Registered date	2014 Year 09 Month 17 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017662