UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024167
Receipt No. R000027670
Scientific Title Analysis of corresponding neuropathology of localization-related epilepsy by PET using an inflammatory ligand, [11C]-DPA713
Date of disclosure of the study information 2016/10/15
Last modified on 2019/04/03

* 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 Analysis of neuropathology of localization-related epilepsy by PET using an inflammatory ligand, [11C]-DPA713
Acronym Analysis neuropathology of localization-related epilepsy using an inflammatory radio-isotope ligand
Scientific Title Analysis of corresponding neuropathology of localization-related epilepsy by PET using an inflammatory ligand, [11C]-DPA713
Scientific Title:Acronym Analysis of neuropathology of localization-related epilepsy using an inflammatory radio-isotope ligand
Region
Japan

Condition
Condition localization related epilepsy
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 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 studied by a neuropathological way.

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 refractory localization related epilepsy (>1 year-old of age), who are treated in Pediatrics and/or Neurosurgery in Osaka University Hospital.
2) Patients who have not received any anti-inflammatory therapy (steroid, gamma globulin etc.)
3)The patients who or whose caregivers gave written informed consent.
Key exclusion criteria 1) Hepatic (AST>100U/L, ALT>100U/L) and / or renal (Cr>1.3mg/dl, BUN>30mg/dl) dysfunction
2) The patients who were treated by steroid or globulin within 6 months.
3) The patients who have been treated with immunosuppresant.
4) Woman who is pregnant, breast-feeding and may become pregnant.
5) The patients whose attending physician jugged that participating in this study as inadequacy.
Target sample size 30

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
Email 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
Email kuriko@ped.med.osaka-u.ac.jp

Sponsor
Institute Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

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
Email 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
2021 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 26 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027670

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.