UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043744 |
|---|---|
| Receipt number | R000049940 |
| Scientific Title | Clinical evaluation of [18F]THK5351 in neurological disorder |
| Date of disclosure of the study information | 2021/03/25 |
| Last modified on | 2022/03/31 13:26:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yuka@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
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
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
Suspended
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
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.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 |
