UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044752 |
|---|---|
| Receipt number | R000050491 |
| Scientific Title | Study on the pathophysiology of epilepsy using a [18F]BCPP-EF PET tracer |
| Date of disclosure of the study information | 2021/07/04 |
| Last modified on | 2023/07/06 17:19:27 |
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Basic information
Public title
Study on the pathophysiology of epilepsy using a [18F]BCPP-EF PET tracer
Acronym
Microglia and mitochondria PET
Scientific Title
Study on the pathophysiology of epilepsy using a [18F]BCPP-EF PET tracer
Scientific Title:Acronym
Microglia and mitochondria PET
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify the brain regions showing altered mitochondria functions and neuroinflammation and clarify the pathophysiology of epilepsy using PET tracers for mitochondria and neuroinflammation.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Elucidation of pathophysiology of epilepsy by examining the binding of [18F]BCPP-EF and [11C]DPA713PET tracers between epilepsy and normal control group.
Key secondary outcomes
Correlation of the PET tracer binding with clinical information, electroencephalogram, neuroimaging examinations and psychological date.
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
| Other |
Interventions/Control_1
PET measurement after intravenous tracer injection
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy participants aged 18 to 75 years
2. Individuals who have no history of psychiatric and neurological disease
3. Individuals who are consent to participate in this study
4. Patients with epilepsy (aged 18 to 75 years)
Key exclusion criteria
1. Individuals who are suspected pregnant, pregnant or breast-feeding.
2. Individuals who have a history of claustrophobia.
3. Individuals who are considered unsuitable by doctors in charge.
4. Individuals with undergoing diabetes treatments who have the blood glucose level over 190mg/dl before PET examination.
In other day, less than 190mg/dl is enable.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuomi |
| Middle name | |
| Last name | Ouchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Biofunctional Imaging
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2466
ouchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuomi |
| Middle name | |
| Last name | Ouchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Biofunctional Imaging
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2466
Homepage URL
ouchi@hama-med.ac.jp
Sponsor or person
Institute
Department of Biofunctional Imaging,
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hamamatsu Medical Photonics Foundation
NHO, National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders
Hamamatsu Photonics
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel
053-435-2466
ouchi@hama-med.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-35
Org. issuing International ID_1
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Study ID_2
No 169, C037
Org. issuing International ID_2
Hamamatsu Medical Photonics Foundation
IND to MHLW
Institutions
Institutions
浜松医科大学（静岡県）、浜松PET診断センター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2025 | 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 | 07 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050491
