UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035715
Receipt number R000040641
Scientific Title Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography
Date of disclosure of the study information 2019/02/13
Last modified on 2019/02/13 17:28:49

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Basic information

Public title

Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography

Acronym

Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography

Scientific Title

Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography

Scientific Title:Acronym

Investigation of subclavian artery visualization in non-contrast asynchronous MR Angiography

Region

Japan


Condition

Condition

Subclavian artery stenosis

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

REACT (Reaction (React) (Relaxation Enhanced Angiography without Contrast & Triggering), which is a novel technique for obtaining a clear image of a blood vessel without using a contrast medium and furthermore without having to adjust the timing to the patient's breathing and heartbeat By using it we decided to engage in research to verify the possibility that the burden on the patient is small and clear images can be obtained.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual evaluation
Signal value change

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

expanded access

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Other

Interventions/Control_1

Intervention test on MRI examination

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

25 years-old <=

Age-upper limit

50 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy person

Key exclusion criteria

People without medical history

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name yuka hirose

Organization

National Hospital Organization Kyushu Medical Center

Division name

Radiation section

Zip code


Address

8th No.1, Chuo-ku, Fukuoka city

TEL

092-852-0700

Email

yuka.h0805@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name yuka hirose

Organization

National Hospital Organization Kyushu Medical Center

Division name

Radiation section

Zip code


Address

8th No.1, Chuo-ku, Fukuoka city

TEL

092-852-0700

Homepage URL


Email

yuka.h0805@gmail.com


Sponsor or person

Institute

National Hospital Organization Kyushu Medical Center (Clinical Research Center)

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization Kyushu Medical Center (Clinical Research Center)

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

yhirose-fkok

Org. issuing International ID_1

20190122-185037

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 02 Month 13 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

No longer recruiting

Date of protocol fixation

2018 Year 10 Month 30 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 30 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 30 Day

Last modified on

2019 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040641


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name