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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029935
Receipt No. 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

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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
Email 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
Email kkudo@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034198

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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