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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028938
Receipt No. 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

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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
Email 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
Email t-takamura@juntendo.ac.jp

Sponsor
Institute Juntendo University
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 Juntendo University Hospital
Address Hongo, Bunkyo-ku, Tokyo 2-1-1
Tel 03-3813-3111
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033102

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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