UMIN-CTR Clinical Trial

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