UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042205
Receipt number R000048177
Scientific Title Application of Chemical Exchange Saturation Transfer Magnetic Resonance Imaging to the CNS disorder
Date of disclosure of the study information 2020/12/01
Last modified on 2022/04/25 10:41:18

* 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

Application of Chemical Exchange Saturation Transfer Magnetic Resonance Imaging to the CNS disorder

Acronym

CEST MRI of the CNS disorder

Scientific Title

Application of Chemical Exchange Saturation Transfer Magnetic Resonance Imaging to the CNS disorder

Scientific Title:Acronym

CEST MRI of the CNS disorder

Region

Japan


Condition

Condition

CNS disorder

Classification by specialty

Neurology Radiology Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate CNS disorder with CEST-MR

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

diagnostic performance

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

Device,equipment

Interventions/Control_1

CEST-MRI acquisition with PET/MRI

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


Not applicable

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Participants who is suspected to have CNS disorder and agree to underwent PET/MRI

Key exclusion criteria

(1) unstable patients
(2) pediatric patients without care-giver
(3) first trimester pregnant patients

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Yasutaka
Middle name
Last name Fushimi

Organization

Kyoto University Hospital

Division name

Department of Diagnostic Imaging and Nuclear Medicine

Zip code

6068507

Address

Shogoin-Kawahara cho 54 Sakyo-ku Kyoto

TEL

0757513760

Email

yfushimi@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Akihiko
Middle name
Last name Sakata

Organization

Kyoto University Hospital

Division name

Department of Diagnostic Imaging and Nuclear Medicine

Zip code

6068507

Address

Shogoin-Kawahara cho 54 Sakyo-ku Kyoto

TEL

0757513760

Homepage URL


Email

asakata@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital

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

Kyoto University Hospital

Address

Shogoin-Kawahara cho 54 Sakyo-ku Kyoto

Tel

0757514748

Email

ethcom@kuhp.kyoto-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



Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 01 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

Preinitiation

Date of protocol fixation

2020 Year 10 Month 22 Day

Date of IRB


Anticipated trial start date

2020 Year 12 Month 01 Day

Last follow-up date

2026 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 22 Day

Last modified on

2022 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048177


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name