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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029189
Receipt No. R000033370
Scientific Title Evaluation of rapid measurement method of cerebral metabolic rate of oxygen and cerebral blood flow using 15O-labeled Gas positron emission tomography compared with steady state method.
Date of disclosure of the study information 2017/09/20
Last modified on 2019/05/20

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Basic information
Public title Evaluation of rapid measurement method of cerebral metabolic rate of oxygen and cerebral blood flow using 15O-labeled Gas positron emission tomography compared with steady state method.
Acronym Evaluation of rapid measurement method of CMRO2 and CBF using 15O-labeled Gas PET compared with steady state method.
Scientific Title Evaluation of rapid measurement method of cerebral metabolic rate of oxygen and cerebral blood flow using 15O-labeled Gas positron emission tomography compared with steady state method.
Scientific Title:Acronym Evaluation of rapid measurement method of CMRO2 and CBF using 15O-labeled Gas PET compared with steady state method.
Region
Japan

Condition
Condition cerebral vascular disease
Classification by specialty
Neurology Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We have used steady state method to measure CBF and CMRO2 until now, but it needs several hours.
Now we prepare circumstances to be able to measure CBF and CMRO2 with rapid method, and we compare those values between the rapid method and the steady state method.
If there is no differentiation of the measurements between the rapid method and the steady state method, we will use the rapid method, and we can expect reduction of patients' burden.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes cerebral blood flow, cerebral metabolic rate of oxygen
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 We measure cerebral blood flow and cerebral metabolic rate of oxygen by the steady state method. During the test, we collect blood from an artery and measure the blood radioactivity. Thereafter, we measure cerebral blood flow and cerebral metabolic rate of oxygen by the rapid method.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patient who take the order of measurement of CBF and CMRO2 by the doctor and agree to our study.
Key exclusion criteria Patient who is under 20 years old.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Akihiko
Middle name
Last name Iida
Organization Nagoya City Rehabilitation Agency
Division name Department of Diagnostic Radiology
Zip code 4678622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Email a-iida@nagoya-rehab.or.jp

Public contact
Name of contact person
1st name Akihiko
Middle name
Last name Iida
Organization Nagoya City Rehabilitation Agency
Division name Department of Diagnostic Radiology
Zip code 4678622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Homepage URL
Email a-iida@nagoya-rehab.or.jp

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) National Cerebral and Cardiovascular Center

IRB Contact (For public release)
Organization Nagoya City Rehabilitation Agency
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel 052-835-3811
Email soumubu@nagoya-rehab.or.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 名古屋市総合リハビリテーション事業団(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 20 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 10
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 30 Day
Date of IRB
2017 Year 10 Month 02 Day
Anticipated trial start date
2017 Year 10 Month 02 Day
Last follow-up date
2018 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 19 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033370

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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