UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000033395
Receipt number R000038075
Scientific Title Evaluating a novel method of unenhanced abdominal MR angiography using the ultrashort TE method.
Date of disclosure of the study information 2018/07/17
Last modified on 2019/07/17 21:37:48

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Basic information

Public title

Evaluating a novel method of unenhanced abdominal MR angiography using the ultrashort TE method.

Acronym

Evaluation of MR angiography using the ultrashort TE method.

Scientific Title

Evaluating a novel method of unenhanced abdominal MR angiography using the ultrashort TE method.

Scientific Title:Acronym

Evaluation of MR angiography using the ultrashort TE method.

Region

Japan


Condition

Condition

Normal subjects

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify optimal method of non-enhanced abdominal MR angiography using the ultrashort TE (UTE) method compared with conventional method.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Optimization of the method of abdominal MR angiography using UTE method compared with conventional method.

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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Normal subjects

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

20 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Normal volunteers who have no history of any abdominal disorders.

Key exclusion criteria

Subjects who have claustrophobia

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Ohta

Organization

Tohoku University Hospital

Division name

Diagnostic Radiology

Zip code

980-8574

Address

1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan 980-8574

TEL

022-717-7312

Email

h-ota@rad.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Atsuro
Middle name
Last name Masuda

Organization

Tohoku University Hospital

Division name

Diagnostic Radiology

Zip code

980-8574

Address

1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan 980-8574

TEL

022-717-7312

Homepage URL


Email

a.masuda@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research support section, General affairs division, Tohoku University School of Medicine

Address

2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan 980-8574

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

2018 Year 07 Month 17 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

10

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 07 Month 17 Day

Date of IRB

2018 Year 08 Month 20 Day

Anticipated trial start date

2018 Year 08 Month 01 Day

Last follow-up date

2020 Year 08 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

2018 Year 07 Month 15 Day

Last modified on

2019 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038075


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name