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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030665
Receipt No. R000035011
Scientific Title Contrast enhanced black blood MR imaging for flow diverter stent placement
Date of disclosure of the study information 2018/02/28
Last modified on 2018/01/03

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Basic information
Public title Contrast enhanced black blood MR imaging for flow diverter stent placement
Acronym Gd-MRI for FD stent
Scientific Title Contrast enhanced black blood MR imaging for flow diverter stent placement
Scientific Title:Acronym Gd-MRI for FD stent
Region
Japan

Condition
Condition cerebral aneurysm
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison between conventional Gd-enhanced MR
and Gd-enhanced black-blood MRI will be performed for patients with pre- and post-flow diverter stent placement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of aneurysmal wall, size, and blood signal suppression.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with cerebral aneurysms who underwent conventional Gd-MRI and Gd-BB-MRI
Key exclusion criteria Poor image
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaori Togashi
Organization Kyoto University Graduate School of Medicine
Division name Department of Diagnostic Imaging and Nuclear Medicine
Zip code
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL 075-751-3760
Email nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasutaka Fushimi
Organization Kyoto University Graduate School of Medicine
Division name Department of Diagnostic Imaging and Nuclear Medicine
Zip code
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL 075-751-3760
Homepage URL
Email nmdioffice@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 28 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
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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2018 Year 01 Month 03 Day
Last modified on
2018 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035011

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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