UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009953 |
|---|---|
| Receipt number | 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 10:29:46 |
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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
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
kokudo@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical Univerisity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011143
