UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028938 |
|---|---|
| Receipt number | R000033102 |
| Scientific Title | Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2021/03/10 10:06:00 |
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Basic information
Public title
Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease
Acronym
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
Scientific Title:Acronym
Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease
Region
| Japan |
Condition
Condition
occulusive cerebrobascular disease(moyamoya disease, ICA stenosis)
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of the SMS DSC MRI for the diagnosis of occulusive cerebrobascular diseases including moyamoya disease or the other erebrobascular diseases such as ICA stgenosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The perfusion measurements as well as the image quality of CBF, CBV, MTT, TTP, Tmax maps, created with temporal resolution of 0.5s (high temporal resoltuion), and conventional temporal resolution of 1.0, 1.5, and 2.0s (low temopral resolution).
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
administration of gadolimium contrast media
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients with occulusive cerebrobascular disease scheduled for perfusuion MRI examination.
Key exclusion criteria
Patietns with a contraindication for the administration of gadolinium contrast media.
Patients determinded to be ineligible to principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Aoki |
Organization
Juntendo University School of Medicine
Division name
Department of Radiology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyoku, Tokyo, 113-8421, Japan
TEL
+81-3-3813-3111
saoki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Takamura |
Organization
Juntendo University School of Medicine
Division name
Department of Radiology
Zip code
113-8421
Address
211 Hongo Bunkyoku Tokyo Japan
TEL
03-3813-3111
Homepage URL
t-takamura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
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
Juntendo University Hospital
Address
Hongo, Bunkyo-ku, Tokyo 2-1-1
Tel
03-3813-3111
juntencrc@juntendo.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
| 2017 | Year | 09 | Month | 01 | 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
37
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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033102
