UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030665
Receipt number 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 13:48:00

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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 or person

Institute

Kyoto University

Institute

Department

Personal name



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

Value
https://center6.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