UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025984 |
|---|---|
| Receipt number | R000029874 |
| Scientific Title | Evaluation of oxidative stress in patients with neuropsychiatric diseases using PET/MRI imaging |
| Date of disclosure of the study information | 2017/02/03 |
| Last modified on | 2022/08/09 12:47:31 |
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Basic information
Public title
Evaluation of oxidative stress in patients with neuropsychiatric diseases using PET/MRI imaging
Acronym
Oxidative stress imaging in patients with neuropsychiatric diseases
Scientific Title
Evaluation of oxidative stress in patients with neuropsychiatric diseases using PET/MRI imaging
Scientific Title:Acronym
Oxidative stress imaging in patients with neuropsychiatric diseases
Region
| Japan |
Condition
Condition
Neuropsychiatric diseases
Classification by specialty
| Neurology | Psychiatry | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate oxidative stress in patients with neuropsychiatric diseases using 64Cu-ATSM PET/MRI imaging.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate oxidative stress in patients with neuropsychiatric diseases using 64Cu-ATSM PET/MRI imaging.
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
Self control
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
PET/MRI, EEG, Neuropsychological tests
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. Patients with neuropsychiatric diseases
2. Healthy volunteers
Key exclusion criteria
Subjects that investigators and medical doctors need to exclude
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Ikawa |
Organization
University of Fukui
Division name
Department of Neurology, University of Fukui Hospital
Zip code
910-1193
Address
23-3 Matsuoka-Shimoaiduki, Eiheiji, Fukui
TEL
0776-61-3111
iqw@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Ikawa |
Organization
University of Fukui
Division name
Department of Neurology, University of Fukui Hospital
Zip code
910-1193
Address
23-3 Matsuoka-Shimoaiduki, Eiheiji, Fukui
TEL
0776-61-3111
Homepage URL
iqw@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
University of Fukui
Address
23-3 Matsuoka-Shimoaiduki, Eiheiji, Fukui
Tel
0776-61-3111
sm-kenkyusien@ml.u-fukui.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
| 2017 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.3390/antiox11051022
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 05 | Month | 22 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2022 | 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
| 2017 | Year | 02 | Month | 03 | Day |
Last modified on
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029874
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
