UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025440
Receipt number 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 22:33:53

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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 or person

Institute

Hamamatsu Univercity school of medicine

Institute

Department

Personal name



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

Value
https://center6.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