UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028312 |
|---|---|
| Receipt number | 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 19:43:49 |
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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
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
kamioka@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
