UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028312
Receipt No. R000032371
Scientific Title Investigation of vascular outflow imaging by 4D-MRAngiography using out flow method
Date of disclosure of the study information 2017/08/01
Last modified on 2019/07/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Investigation of vascular outflow imaging by 4D-MRAngiography using out flow method
Acronym Investigation of vascular outflow imaging by 4D-MRAngiography
Scientific Title Investigation of vascular outflow imaging by 4D-MRAngiography using out flow method
Scientific Title:Acronym Investigation of vascular outflow imaging by 4D-MRAngiography
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will take 3D-MRA, 4D-MRA (in flow method) and new method (out flow method) for healthy volunteers and examine the usefulness of out flow method by comparing cerebrovascular visualization ability.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual evaluation is performed on vascular visualization ability of each blood vessel image by MRI. Scoring visualization abilities for major blood vessels and peripheral blood vessels.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 One time MRI scan (about 30 minutes)
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1. Healthy people aged 20 or over, 70 years old or younger when acquiring consent.
Definition of a healthy person: A person who has no abnormal findings in medical examination done within the past year and who has no disease under treatment.
2. Person who offered participation offer by seeing the bulletin of this research.
3. Those who understand the contents of this research and obtained consent in writing.
Key exclusion criteria 1. Persons with prosthetic and dentures to be attached by magnetic force
2. Person who has embedded MRI non-compliant metal
3. Persons who are difficult to rest during imaging
4. Those with a tattoo (due to the possibility of burns)
5. Persons who have a history of brain diseases
6. Persons who are likely to become pregnant or pregnant women
7. Others inappropriate for conducting this research
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name Awai
Organization Hiroshima University Hospital
Division name Department of Radiology
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima city, Htoshima, Japan
TEL 082-257-5555
Email awai@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Shogo
Middle name
Last name Kamioka
Organization Hiroshima University Hospital
Division name Department of Medical support
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima city, Htoshima, Japan
TEL 082-257-5564
Homepage URL
Email kamioka@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hiroshima University Hospital
Address 1-2-3 Kasumi, Minami-ku, Hiroshima city, Htoshima, Japan
Tel 082-257-1732
Email protocol@cimr.hiroshima-u.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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 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
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 06 Month 23 Day
Date of IRB
2017 Year 06 Month 23 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032371

Research Plan
Registered date File name
2018/07/26 【Final倫理審査委員会提出】臨床研究計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.