UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028771 |
|---|---|
| Receipt number | R000032924 |
| Scientific Title | Clinical feasibility of ASL-MRI to assess perfusional delay in cerebrovascular disease |
| Date of disclosure of the study information | 2017/08/23 |
| Last modified on | 2021/08/25 15:57:59 |
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Basic information
Public title
Clinical feasibility of ASL-MRI to assess perfusional delay in cerebrovascular disease
Acronym
ASL-MRI in cerebrovascular disease
Scientific Title
Clinical feasibility of ASL-MRI to assess perfusional delay in cerebrovascular disease
Scientific Title:Acronym
ASL-MRI in cerebrovascular disease
Region
| Japan |
Condition
Condition
cerebrovascular disease (moyamoya disease, atherosclerotic cerebrovascular disease, stroke, arteriovenous malformation etc.)
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify clinical feasibility of ASL ratio calculated from ASL-MRI using two postlabeling delay in patients with cerebrovascular disease
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. correlation with other modalities (PET, SPECT, DSC)
2. difference among disease (moyamoya disease and atherosclerotic cerebrovascular disease etc.) and normal subjects
3. chronological change including postoperative change
4. difference among age
5. correlation between arterial transit time calculated from ASL-MRI using 5 postlabeling delays and ASL ratio in normal subjects
Key secondary outcomes
NA
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. All patients with cerebrovascular disease evaluated with ASL-MRI (retrospective group: 2011/4/1-2017/9/30. Any age, any tyepe of cerebrovascular disease)
2. All patients with cerebrovascular disease evaluated with ASl-MRI (prospective group: 2017/9/30-2020/6/30. Any age, any tyepe of cerebrovascular disease)
3. Normal subjects (>=20 year-old, no upper limit)
Key exclusion criteria
*denial from the patient
*neurological disease other than cerebrovascular disease (brain tumor, epilepsy, etc)
*unable to perform MRI
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Yoji |
| Middle name | |
| Last name | Tanaka |
Organization
Tokyo Medical and Dental University
Division name
Neurosurgery
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyoku,Tokyo
TEL
03-5803-5266
tanaka.nsrg@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Hara |
Organization
Tokyo Medical and Dental University
Division name
Neurosurgery
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyoku, Tokyo
TEL
0358035266
Homepage URL
shara.nsrg@tmd.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Tokyo Medical and Dental 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
Clinical Reserch Center
Address
1-5-45, Yushima, Bunkyoku, Tokyo
Tel
03-5803-5612
tiken.crc@tmd.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
東京医科歯科大学医学部脳神経機能外科学分野（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 31 | Day |
Other
Other related information
not applicable
Management information
Registered date
| 2017 | Year | 08 | Month | 22 | Day |
Last modified on
| 2021 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032924
