UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033382
Receipt number 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 16:49:50

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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 or person

Institute

Fukushima Medical University

Institute

Department

Personal name



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

Value
https://center6.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