UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040168 |
|---|---|
| Receipt number | R000045781 |
| Scientific Title | Development and clinical application of superselective 4D-MRA for intracranial blood vessels |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2023/10/18 12:56:32 |
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Basic information
Public title
Development and clinical application of superselective 4D-MRA for intracranial blood vessels
Acronym
Development and clinical application of superselective 4D-MRA for intracranial blood vessels
Scientific Title
Development and clinical application of superselective 4D-MRA for intracranial blood vessels
Scientific Title:Acronym
Development and clinical application of superselective 4D-MRA for intracranial blood vessels
Region
| Japan |
Condition
Condition
Cerebrovascular disease
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the development and clinical application of superselective 4D-MRA in intracranial blood vessels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Establishment of optimal imaging parameters and imaging method
Key secondary outcomes
Shortened acquisition time and improved temporal resolution
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention test on MRI examination
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
Subject with contraindications to MRI
Subject with metallic implants
Claustrophobic
Pregnant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Togao |
Organization
Kyushu University Hospital
Division name
Radiology
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka
TEL
092-642-5695
togao@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Togao |
Organization
Kyushu University Hospital
Division name
Radiology
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka
TEL
092-642-5695
Homepage URL
togao@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Center for Clinical and Translational Research of Kyushu University Hospital
Address
3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka
Tel
092-642-5774
bynintei@jimu.kyushu-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | 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
11
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045781
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
