|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-jRCTs031180017 |
|
Date of registration:
|
07/09/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease
|
|
Scientific title:
|
Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease - SMS DSC-MRI study for the occulusive cerebrobascular disease |
|
Date of first enrolment:
|
01/08/2018 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Complete |
|
URL:
|
https://jrct.niph.go.jp/latest-detail/jRCTs031180017 |
|
Study type:
|
Interventional |
|
Study design:
|
single arm study, open(masking not used), uncontrolled control, single assignment, diagnostic purpose
|
|
Phase:
|
N/A
|
|
|
Contacts
|
|
Name:
|
Shigeki
Aoki |
|
Address:
|
2-1-1 Hongo, Bunkyoku, Tokyo, 113-8421, Japan
113-8431
Tokyo
Japan |
|
Telephone:
|
+81-3-5802-1230 |
|
Email:
|
saoki@juntendo.ac.jp |
|
Affiliation:
|
Department of Radiology, Juntendo University School of Medicine |
|
|
Name:
|
Shigeki
Aoki |
|
Address:
|
2-1-1 Hongo, Bunkyoku, Tokyo, 113-8421, Japan
113-8431
Tokyo
Japan |
|
Telephone:
|
+81-3-5802-1230 |
|
Email:
|
saoki@juntendo.ac.jp |
|
Affiliation:
|
Juntendo University School of Medicine |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: patients with occlusive cerebrovascular disease scheduled to undergo perfusion MRI examination.
Exclusion criteria: contraindications to MRI examination or gadolinium contrast medium
pregnancy, possibility of pregnancy, or breastfeeding
In addition, patients who were judged to be inappropriate as study subjects by study manager.
Age minimum:
>= 20age old
Age maximum:
Not applicable
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
carotid artery stenosis, moyamoya disease
|
|
Intervention(s)
|
|
Intravenous administration of gadobutrol (Gadovist, Bayer Schering Pharma, Berlin, Germany) is administered in the supine position, and high speed DSC-MRI scan by using SMS acquisition (temporal resolution of 0.5s) is carried out at the same time as injection of the contrast agent with an acquisition time of 70sec. The quantitative and qualitative comparison between reference data set (0.5s) and additional data sets with temporal resolution of 1.0s, 1.5s, and 2.0s generated from the reference data set, is performed.
|
|
Primary Outcome(s)
|
|
To compare the perfusion parameters including CBF, CBV, MTT, TTP, and Tmax between SMS DSC-MRI and conventional DSC-MRI in patients with occlusive cerebrovascular disease.
|
|
Secondary Outcome(s)
|
|
To evaluate the relationship between CBF map calculated by using DSC-MRI and that by SPECT, as well as to compare the accuracy of correlation to SPECT between SMS DSC-MRI and conventional DSC-MRI.
|
|
Secondary ID(s)
|
|
UMIN000028938
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approval
Approval date: 07/08/2018
Contact:
kenkyu5858@juntendo.ac.jp
Juntendo Hospital Certified Review Board
+81-3-5802-1584
kenkyu5858@juntendo.ac.jp
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
31/07/2021 |
|
Date Completed:
|
25/12/2019 |
|
URL:
|
|
|
|