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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000025440
Receipt No. R000029262
Scientific Title Optimization of Gadobutrol injection protocol for contrast-enhanced MR angiography in abdomen-lower extremity. ~Investigation in healthy volunteers~
Date of disclosure of the study information 2017/01/11
Last modified on 2018/12/29

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Basic information
Public title Optimization of Gadobutrol injection protocol for contrast-enhanced MR angiography in abdomen-lower extremity. ~Investigation in healthy volunteers~
Acronym Gadobutrol MRA of abdomen-lower extremity in healthy volunteers
Scientific Title Optimization of Gadobutrol injection protocol for contrast-enhanced MR angiography in abdomen-lower extremity. ~Investigation in healthy volunteers~
Scientific Title:Acronym Gadobutrol MRA of abdomen-lower extremity in healthy volunteers
Region
Japan

Condition
Condition Peripheral arterial obstruction diseases
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is optimization of Gadobutrol injection protocol of abdomen-lower extremity MRA. Two different injection speed protocol are prepared, and healthy volunteers are separeted into two groups. Each group is injected Gadobutrol in accordance with either protocol. We compare each group's visualization of abdomen-lower extremity MRA.

Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Signal-to-noise-ratio and contrast-noise-ratio of Abdominal aorta, bilateral renal artery, iliac artery, femoral artery, popliteal artery, peroneal artery, anterior and posterior tibial artery.
Key secondary outcomes 1.Assessment of visualization in each artery
2.Presence of artifact
3.Presence of vein contamination
4.Assessment of intra- and inter-obserber agreement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Gadobutrol is injected at a rate of 2ml/sec as for abdominal MRA, and 1ml/sec as for lower extremity MRA.
Gadobutrol injection dose is decided 0.1ml/kg(Gadobutrol recomended dose in Japan). A half of dose is injected in each abdominal and lower extremity MRA.
Interventional term is one day. Number of Gadobutrol administration time is two(A half of recomended dose uses twice).
Interventions/Control_2 Gadobutrol is injected at a rate of 1ml/sec as for abdominal MRA, and 0.5ml/sec as for lower extremity MRA.Total Gadobutrol dose, number of administration, interventional term are same as Interventions 1.
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Male and Female obtained written informed consent, not less than thirty years old.
Key exclusion criteria 1.People who have past history of cardiovascular or arterial disease.
2.Woman who is pregnant,may be pregnant,or is breastfeeding.
3.People who had allergic history of contrast enhanced media.
4.People who can not take MRI(for example,people who have claustrophobia,devices which is unsupported for MRI,etc)
5.People who is judged inadequate by researchers.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takasuke Ushio
Organization Hamamatsu Univercity school of medicine
Division name Department of diagnostic radiology and nuclear medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL 053-435-2242
Email tushio@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takasuke Ushio
Organization Hamamatsu Univercity school of medicine
Division name Department of diagnostic radiology and nuclear medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL 053-435-2242
Homepage URL
Email tushio@hama-med.ac.jp

Sponsor
Institute Hamamatsu Univercity school of medicine
Institute
Department

Funding Source
Organization Bayer Yakuhin,Ltd
Organization
Division
Category of Funding Organization Profit organization
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 浜松医科大学附属病院(静岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2016 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 11 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded
2018 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2018 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029262

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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