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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009953
Receipt No. R000011143
Scientific Title Cerebral Blood Flow Measurement of MRI using PSO17 in Normal Subjects and Patients with Chronic Cerebrovascular Disorders
Date of disclosure of the study information 2013/02/04
Last modified on 2017/06/19

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Basic information
Public title Cerebral Blood Flow Measurement of MRI using PSO17 in Normal Subjects and Patients with Chronic Cerebrovascular Disorders
Acronym Cerebral Blood Flow Measurement using PSO17
Scientific Title Cerebral Blood Flow Measurement of MRI using PSO17 in Normal Subjects and Patients with Chronic Cerebrovascular Disorders
Scientific Title:Acronym 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
1st name
Middle name
Last name Makoto Sasaki
Organization Iwate Medical University
Division name Ultrahigh Field MRI
Zip code
Address 19-1 Uchimaru, Morioka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kohsuke Kudo
Organization Iwate Medical University
Division name Ultrahigh Field MRI
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 04 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
2012 Year 11 Month 28 Day
Date of IRB
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

Other
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

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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