UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015981 |
|---|---|
| Receipt number | R000018589 |
| Scientific Title | Cerebral Blood Flow Measurement of MRI using O-17 labeled water in Normal Subjects and Patients with Chronic Cerebrovascular Disorders |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2019/03/03 00:10:43 |
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Basic information
Public title
Cerebral Blood Flow Measurement of MRI using O-17 labeled water in Normal Subjects and Patients with Chronic Cerebrovascular Disorders
Acronym
Cerebral Blood Flow Measurement using O-17 labeled water
Scientific Title
Cerebral Blood Flow Measurement of MRI using O-17 labeled water in Normal Subjects and Patients with Chronic Cerebrovascular Disorders
Scientific Title:Acronym
Cerebral Blood Flow Measurement using O-17 labeled water
Region
| Japan |
Condition
Condition
normal subjects and patients with chronic cerebrovascular disorders
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
feasibility evaluation of O-17 labeled water
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Signal difference of brain parenchyma between pre- and post-administration of O-17 labeled water and saline
Key secondary outcomes
(1)Efficacy
1)Temporal signal change after administration of O-17 labeled water and saline
2)Correlation between blood flow image and PET in patient group
(2)Safety
1) Vital signs (BP, HR, body temperature)
2) Adverse effect
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
| Medicine |
Interventions/Control_1
intravenous administration of O-17 labeled water
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
Step1(Normal subjects)
(1)healthy Japanese male (20 - 65 years old)
(2)body weight < 60 kg
(3)informed consent is obtained
Step2(Patients)
(1)Stenosis or occlusion of major craniocervical arteries in MRA, diagnosed within 90 days before obtaining informed consent
(2)Diminished regional cerebral blood flow (CBF) in SPECT/PET, diagnosed within 90 days before obtaining informed consent
(3)Japanese male (20 - 65 years old)
(4)body weight < 60 kg
(5)informed consent is obtained
Key exclusion criteria
Step1(Normal subjects)
(1)metallic implant or claustrophobia
(2)chronic disorders
(3)CNS, liver, kidney or heart diease
(4)acute infection before 30 days
(5)drug allergy
(6)chronic intake of drugs (> 30 days)
(7)other clinical trial
(8)willing to have babies
(9)person who is contraindicated for this study due to other reasons
Step2(Patients)
(1)metallic implant or claustrophobia
(2)unstable cardiac function
(3)severe hepatic or renal disorders
(4)acute infection before 30 days
(5)drug allergy
(6)screening test
(7)willing to have babies
(8)other clinical trial
(9)person who is contraindicated for this study due to other reasons
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohsuke Kudo |
Organization
Hokkaido University Hospital
Division name
department of radiology
Zip code
Address
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
kkudo@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohsuke Kudo |
Organization
Hokkaido University Hospital
Division name
department of radiology
Zip code
Address
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
kkudo@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)/Translational Research Network Program
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
Address
Tel
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
| 2015 | Year | 01 | Month | 05 | 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
| 2014 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018589
