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 |
Optimization of Gadobutrol injection protocol for contrast-enhanced MR angiography in abdomen-lower extremity. ~Investigation in healthy volunteers~
Gadobutrol MRA of abdomen-lower extremity in healthy volunteers
Optimization of Gadobutrol injection protocol for contrast-enhanced MR angiography in abdomen-lower extremity. ~Investigation in healthy volunteers~
Gadobutrol MRA of abdomen-lower extremity in healthy volunteers
Japan |
Peripheral arterial obstruction diseases
Radiology |
Others
NO
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.
Bio-equivalence
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.
1.Assessment of visualization in each artery
2.Presence of artifact
3.Presence of vein contamination
4.Assessment of intra- and inter-obserber agreement
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Diagnosis
Medicine |
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).
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.
30 | years-old | <= |
Not applicable |
Male and Female
Male and Female obtained written informed consent, not less than thirty years old.
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.
40
1st name | |
Middle name | |
Last name | Takasuke Ushio |
Hamamatsu Univercity school of medicine
Department of diagnostic radiology and nuclear medicine
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
053-435-2242
tushio@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Takasuke Ushio |
Hamamatsu Univercity school of medicine
Department of diagnostic radiology and nuclear medicine
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
053-435-2242
tushio@hama-med.ac.jp
Hamamatsu Univercity school of medicine
Bayer Yakuhin,Ltd
Profit organization
NO
浜松医科大学附属病院(静岡県)
2017 | Year | 01 | Month | 11 | Day |
Partially published
Main results already published
2016 | Year | 10 | Month | 20 | Day |
2017 | Year | 01 | Month | 11 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 10 | Month | 01 | Day |
2018 | Year | 11 | Month | 30 | Day |
2016 | Year | 12 | Month | 27 | Day |
2018 | Year | 12 | Month | 29 | Day |
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 |