UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cerebral Blood Flow Measurement of MRI using PSO17 in Normal Subjects and Patients with Chronic Cerebrovascular Disorders
Title of the study (Brief title)	Cerebral Blood Flow Measurement using PSO17
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	safety and feasibility evaluation of PSO17
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	(1) Signal difference of brain parenchyma between pre- and post-administration of PSO17 and saline (2) Temporal signal change after administration of PSO17 and saline
Key secondary outcomes	(1) Efficacy 1) Correlation between blood flow image and PET in patient group (2) Safety 1) Vital signs (BP, HR, body temperature) 2) blood test and urine test 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
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	(1) healthy Japanese male (20 - 65 years old) (2) body weight < 60 kg (3) informed consent is obtained
Key exclusion criteria	(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) screening test (9) willing to have babies
Target sample size	17

Research contact person
Name of lead principal investigator	Makoto Sasaki
Organization	Iwate Medical University
Division name	Ultrahigh Field MRI
Address	19-1 Uchimaru, Morioka
TEL
Email

Public contact
Name of contact person	Kohsuke Kudo
Organization	Iwate Medical University
Division name	Ultrahigh Field MRI
Address
TEL	019-651-5111
Homepage URL
Email	kokudo@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical Univerisity
Institute
Department

Funding Source
Organization	Cabinet office
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 28 Day
Anticipated trial start date	2012 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 02 Month 04 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011143