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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033395
Receipt No. 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

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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
Institute Tohoku University
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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