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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043744
Receipt No. R000049940
Scientific Title Clinical evaluation of [18F]THK5351 in neurological disorder
Date of disclosure of the study information 2021/03/25
Last modified on 2021/03/25

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Basic information
Public title Clinical evaluation of [18F]THK5351 in neurological disorder
Acronym Clinical evaluation of [18F]THK5351 in neurological disorder
Scientific Title Clinical evaluation of [18F]THK5351 in neurological disorder
Scientific Title:Acronym Clinical evaluation of [18F]THK5351 in neurological disorder
Region
Japan

Condition
Condition neurological disorder
Classification by specialty
Neurology Geriatrics Psychiatry
Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the pathophysiological mechanism of neurological disorders using Fluorine-18-labeled THK5351 PET
Basic objectives2 Others
Basic objectives -Others pathophysiological mechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Uptake of Fluorine-18-labeled THK5351 PET
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
Interventions/Control_1 [18F]THK5351 PET/CT studies will be performed in patients. PET images of the brain will be acquired 50 min after intravenous injection of 3.7 MBq/kg [18F]THK5351.
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 Neurological disorders
Key exclusion criteria 1) Pregnant, possibly pregnant
2) Subject who is facing a life crisis
3) Subject who was judged by the investigator to be inappropriate as a participant in this study
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Nishiyama
Organization Faculty of Medicine, Kagawa University
Division name Radiology
Zip code 761-0793
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL 0878985111
Email yuka@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Yuka
Middle name
Last name Yamamoto
Organization Faculty of Medicine, Kagawa University
Division name Radiology
Zip code Radiology
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL 0878985111
Homepage URL
Email yuka@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University
Institute
Department

Funding Source
Organization Kagawa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Faculty of Medicine, Kagawa University
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel 0878985111
Email yuka@med.kagawa-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
2021 Year 03 Month 25 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 Enrolling by invitation
Date of protocol fixation
2020 Year 11 Month 10 Day
Date of IRB
2020 Year 11 Month 10 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2031 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 25 Day
Last modified on
2021 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049940

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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