UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051379 |
|---|---|
| Receipt number | R000058616 |
| Scientific Title | A Novel Cerebral Vascular Imaging Method Using Bidirectional Saturation Pulse Applied Differential Imaging in MRA-TOF Method |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2023/06/19 15:25:30 |
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Basic information
Public title
A Novel Cerebral Vascular Imaging Method Using Bidirectional Saturation Pulse Applied Differential Imaging in MRA-TOF Method
Acronym
A Novel Cerebral Vascular Imaging Method Using Bidirectional Saturation Pulse Applied Differential Imaging in MRA-TOF Method
Scientific Title
A Novel Cerebral Vascular Imaging Method Using Bidirectional Saturation Pulse Applied Differential Imaging in MRA-TOF Method
Scientific Title:Acronym
A Novel Cerebral Vascular Imaging Method Using Bidirectional Saturation Pulse Applied Differential Imaging in MRA-TOF Method
Region
| Japan |
Condition
Condition
Cerebral hemorrhage, subarachnoid hemorrhage
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
MRA-TOF(Magnetic Resonance Angiography - Time of Flight) is one of the imaging methods of MRI, and is widely used in the treatment of central nervous system diseases such as cerebrovascular disorders because it can depict cerebral blood vessels without using contrast media. However, the MRA-TOF method is based on the T1-weighted image of the Gradient Echo method, which has the disadvantage of obscuring the blood vessels in areas overlapping with high-signal lesions on the T1-weighted image, such as hematomas. In the MRA-TOF method, a saturation pulse is usually applied to the head side of the slab to suppress the venous signal, but it is also possible to suppress the arterial signal by applying a saturation pulse to the foot side of the slab (MRV-TOF method). By obtaining the difference image of both (MRA-MRV difference image), it is possible to selectively remove lesions that show high signal in the T1-weighted image and obtain a clear cerebrovascular depiction unaffected by hematoma. Since this method is useful in routine clinical diagnosis, it is already being performed at the discretion of the examining physician. In the future, we will accumulate cases of this method and make it the subject of research. In this study, we will verify the usefulness of a new method (MRA-MRV difference image) for depicting cerebral vascular motion independent of the presence of high-signal lesions on T1-weighted images, such as hematomas.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The usefulness of the images will be evaluated by conducting reading experiments with several diagnostic radiologists on the visibility of cerebral blood vessels in normal MRA-TOF images and MRA-MRV difference images.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included.
1. patients who have undergone or will undergo head MRI/MRA to investigate intracranial hemorrhage between January 2020 and December 31, 2023
2. within 3 weeks of onset of intracranial hemorrhage
3. at least 18 years old
Key exclusion criteria
Patients with any of the following conditions will be excluded from the study:
1. Patients who require urgent and immediate therapeutic intervention
2. patients who are unable to remain at rest during MRI imaging
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sodai |
| Middle name | |
| Last name | Hoshiai |
Organization
University of Tsukuba Hosptial
Division name
Department of Diagnostic and Interventional Radiology
Zip code
3058575
Address
1-1-1, Tennnohdai, Tsukuba, Ibaraki, Japan
TEL
0298533205
hoshiai@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Sodai |
| Middle name | |
| Last name | Hoshiai |
Organization
University of Tsukuba Hospital
Division name
Department of Diagnostic and Interventional Radiology
Zip code
3058575
Address
1-1-1, Tennnohdai, Tsukuba, Ibaraki, Japan
TEL
0298533205
Homepage URL
hoshiai@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital T-CREDO
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
Tel
0298535669
t-credo.adm@un.tsukuba.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
| 2023 | Year | 06 | Month | 20 | 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
| 2023 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Start after approval by the Ethics Committee
Management information
Registered date
| 2023 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058616
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
