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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033382
Receipt No. R000036992
Scientific Title Normal database of cerebral blood flow and oxygen metabolism measured by PET/MRI with oxygen-15 labeled gas
Date of disclosure of the study information 2018/07/13
Last modified on 2019/07/16

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Basic information
Public title Normal database of cerebral blood flow and oxygen metabolism measured by PET/MRI with oxygen-15 labeled gas
Acronym Normal database of O-15 gas PET/MRI
Scientific Title Normal database of cerebral blood flow and oxygen metabolism measured by PET/MRI with oxygen-15 labeled gas
Scientific Title:Acronym Normal database of O-15 gas PET/MRI
Region
Japan

Condition
Condition healthy person
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To construct normal database of cerebral blood flow and metabolism of O-15 gas and compare the cerebral blood flow and metabolism derived from MRI using integrated PET/MRI system.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cerebral blood flow, blood volume, cerebral metabolic rate of oxygen and oxygen extraction fraction by O-15 gas PET are measured and compared to cerebral blood flow and diffusion related parameters measured by MRI.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Healthy person
From 20 to 90 years of age and capable of understanding explanations relating to the participation in this research.
Almost equal male and female number, If possible.
More than six male and females of 40-80-years are included respectively.
Key exclusion criteria other than the above
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Ito
Organization Fukushima Medical University
Division name Department of Radiology and Nuclear Medicine
Zip code 9601295
Address Hikarigaoka 1, Fukushima
TEL +81245471111
Email h-ito@fmu.ac.jp

Public contact
Name of contact person
1st name Shiro
Middle name
Last name Ishii
Organization Fukushima Medical University
Division name Department of Radiology and Nuclear Medicine
Zip code 960-1295
Address Hikarigaoka 1, Fukushima
TEL 0245-47-1111
Homepage URL
Email shirou@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB, Fukushima Medical University
Address Hikarigaoka 1, Fukushima
Tel +81245471111
Email rs@fmu.ac.jp

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
2018 Year 07 Month 13 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 9
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 08 Month 10 Day
Date of IRB
2017 Year 09 Month 15 Day
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is exploratory study to utilize the strength of the integrated PET/MRI system. That is to measure a cerebral blood flow and metabolism using O-15 gas PET and multiparatric MRI sequence acquired simultaneously and clarify relationship and usefulness of these data.

Management information
Registered date
2018 Year 07 Month 13 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036992

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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