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
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
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
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
