UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029935 |
|---|---|
| Receipt number | R000034198 |
| Scientific Title | Cerebral Blood Flow Measurement of MRI using PSO17 in Normal Subjects |
| Date of disclosure of the study information | 2017/11/16 |
| Last modified on | 2018/11/13 10:40:16 |
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Basic information
Public title
Cerebral Blood Flow Measurement of MRI using PSO17 in Normal Subjects
Acronym
Cerebral Blood Flow Measurement using PSO17
Scientific Title
Cerebral Blood Flow Measurement of MRI using PSO17 in Normal Subjects
Scientific Title:Acronym
Cerebral Blood Flow Measurement using PSO17
Region
| Japan |
Condition
Condition
brain infarction, brain tumor, epilepsy
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of PSO17 concentrations calculated by MRI signals with concentrations of arterial blood
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Correlation of PSO17 concentrations between calculated by MRI signals and of arterial blood sampling
Key secondary outcomes
1) Qualitative comparison of PSO17 concentrations calculated by MR signals and of arterial blood sampling
2) vital signs (blood pressure, heart rate, and body temperature)
3) 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 PSO17 and arterial blood collection
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 and Female
Key inclusion criteria
(1) healthy Japanese (20 - 65 years old)
(2) body weight < 80 kg
(3) informed consent is obtained
Key exclusion criteria
(1)metallic implant or claustrophobia
(2)blood flow abnormality by Allen test
(3)chronic disorders
(4)CNS, liver, kidney or heart disease
(5)acute infection before 30 days
(6)drug allergy
(7)chronic intake of drugs (> 30 days)
(8)other clinical trial within 90 days
(9)willing to have babies or during breast feeding
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohsuke Kudo |
Organization
Hokkaido University Hospital
Division name
department of diagnostic and interventional radiology
Zip code
Address
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-7779
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 diagnostic and interventional radiology
Zip code
Address
Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-7779
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
Japanese Governmental office
Nationality of Funding Organization
Japan
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 16 | 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 | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 12 | Day |
Last modified on
| 2018 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034198
| Research Plan | |
|---|---|
| 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 |
