UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024167
Receipt number 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 2023/03/06 18:46:34

* 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 localization related epilepsy (>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

80


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 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

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

2025 Year 03 Month 31 Day

Date of closure to data entry

2025 Year 03 Month 31 Day

Date trial data considered complete

2025 Year 03 Month 31 Day

Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 09 Month 26 Day

Last modified on

2023 Year 03 Month 06 Day



Link to view the page

Value
https://center6.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