UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000033370