UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cerebral Blood Flow Measurement of MRI using PSO17 in Normal Subjects
Title of the study (Brief title)	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	Kohsuke Kudo
Organization	Hokkaido University Hospital
Division name	department of diagnostic and interventional radiology
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	Kohsuke Kudo
Organization	Hokkaido University Hospital
Division name	department of diagnostic and interventional radiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000034198