UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024167 |
|---|---|
| Receipt number | R000027670 |
| Scientific Title | Analysis of corresponding neuropathology of localization-related epilepsy and other childhood-onset neurological disorders by PET using an inflammatory ligand, [11C]-DPA713 |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2025/06/16 16:37:21 |
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Basic information
Public title
Analysis of neuropathology of localization-related epilepsy and other childhood-onset neurological disorders by PET using an inflammatory ligand, [11C]-DPA713
Acronym
Analysis neuropathology of localization-related epilepsy and other childhood-onset neurological disorders using an inflammatory radio-isotope ligand
Scientific Title
Analysis of corresponding neuropathology of localization-related epilepsy and other childhood-onset neurological disorders by PET using an inflammatory ligand, [11C]-DPA713
Scientific Title:Acronym
Analysis of neuropathology of localization-related epilepsy and other childhood-onset neurological disorders using an inflammatory radio-isotope ligand
Region
| Japan |
Condition
Condition
localization related epilepsy and other childhood-onset neurological disorders
Classification by specialty
| Pediatrics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a novel method to enable pathological and distribution of neuroinflammation in localization related epilepsy and other childhood-onset neurological disorders using [11C]-DPA713 PET.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We will qualitatively estimate the uptake of [11C]-DPA713 in a human brain.
Key secondary outcomes
1)We will analyze the association of [11C]DPA713 data and other clinical data, such as clinical manifestation, EEG, MRI, FDG-PET, Iomazenil-SPECT, and MEG.
2)In the patients who undergo epilepsy surgery, the severity of microglial activation is by a neuropathological way.
3) We study the association of neuroinflammation in child-onset neurological disorders.
4) We analyze the efficacy on the neuroinflammation by anti-inflammatory therapy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
[11C]-DPA713 PET-CT
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with localization related epilepsy and other childhood-onset neurological disorders (>1 year-old of age), who are treated in Pediatrics and/or Neurosurgery in Osaka University Hospital.
2)The patients who or whose caregivers gave written informed consent.
Key exclusion criteria
1)Patients with severe hepatic and/or renal dysfunction
2) Woman who is pregnant, breast-feeding and may become pregnant.
3) The patients whose attending physician jugged that participating in this study as inadequacy.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Kuriko |
| Middle name | |
| Last name | Shimono |
Organization
Osaka University Hospital
Division name
Pediatrics, United Graduate School of Child Development
Zip code
565-0871
Address
2-15, Yamadaoka, Suita, Osaka
TEL
06-6879-3863
kuriko@ped.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shimono |
| Middle name | |
| Last name | Kuriko |
Organization
Osaka University Hospital
Division name
Pediatrics
Zip code
565-0871
Address
2-15, Yamadaoka, Suita, Osaka
TEL
06-6879-3863
Homepage URL
kuriko@ped.med.osaka-u.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka university Hospital
Address
2-15, Yamaaoka Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 15 | 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
| 2016 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027670
