UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study using positron emission tomography(PET)
Acronym	PET imaging of Aquapolin-1,4 using TGN020
Scientific Title	Clinical study using positron emission tomography(PET)
Scientific Title:Acronym	PET imaging of Aquapolin-1,4 using TGN020
Region	Japan

Condition
Condition	brain tumor,epilepsy,multiple sclerosis, neuromyelitis,Duchenne musclar dystrophy,Alzheimer's disease,Down Syndrome,Hydrocephalus
Classification by specialty	Neurology Pediatrics Ophthalmology Neurosurgery Adult Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	direct in vivo PET imaging of AQP1,4 distribution
Basic objectives2	Others
Basic objectives -Others	A search of the location of abnormality associated with the distribution of AQP1,4
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	in vivo imaging of the distribution of AQP1,4 and clinical condition elucidation of the disease group associated with AQP1,4
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 Device,equipment
Interventions/Control_1	Image analysis for the distribution of AQP1,4 between normalvolunteer and associated patients (once administration)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy adult volunteer and patients of disease associated with AQP4
Key exclusion criteria	The person that an examination for 30-minute imaging is impossible
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Tsutomu Middle name Last name Nakada
Organization	University of Niigata
Division name	Center for Integrated Human Brain Science
Zip code	951-8585
Address	Asahimatchi 1-757,Chuo-ku,Niigata
TEL	025-227-0683
Email	tnakada@bri.niigata-u.ac.jp

Public contact
1st name of contact person	1st name Yuji Middle name Last name Suzuki
Organization	University of Niigata
Division name	Center for Integrated Human Brain Science
Zip code	951-8585
Address	Asahimatchi 1-757,Chuo-ku,Niigata
TEL	025-227-0683
Homepage URL
Email	yuji-s@bri.niigata-u.ac.jp

Sponsor
Institute	Center for Integrated Human Brain Science, Brain Research Institute, University of Niigata
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sport, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Niigata
Address	Asahimatchi 1-757,Chuo-ku,Niigata
Tel	025-227-2006
Email	shomu@med.niigata-u.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	2011 Year 05 Month 22 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	2011 Year 06 Month 01 Day
Date of IRB	2011 Year 04 Month 14 Day
Anticipated trial start date	2011 Year 06 Month 01 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 05 Month 22 Day
Last modified on	2019 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006648