UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000029191
Receipt No. R000033276
Scientific Title Comparison of the quantitative value acquired by the different cerebral circulation metabolism measurement methods.
Date of disclosure of the study information 2017/09/20
Last modified on 2019/11/20 (Ver. 8)

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Basic information
Public title Comparison of the quantitative value acquired by the different cerebral circulation metabolism measurement methods.
Acronym Comparison of the quantitative value acquired by the different cerebral circulation metabolism measurement methods.
Scientific Title Comparison of the quantitative value acquired by the different cerebral circulation metabolism measurement methods.
Scientific Title:Acronym Comparison of the quantitative value acquired by the different cerebral circulation metabolism measurement methods.
Region
Japan

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

Objectives
Narrative objectives1 In the cerebral metabolism measurements using positron emission tomography, we perform the usual steady state (SS) method and the autoradiography (ARG) method, which can be expected to reduce the inspection time. And, we compare the quantitative value of cerebral blood flow (CBF), oxygen extraction fraction (OEF), cerebral metabolic rate of oxygen (CMRO2), and cerebral blood volume (CBV) between the SS method and the ARG method using our apparatus. Then, we consider replacing the SS method by the ARG method.
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 and 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 SS 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 ARG 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 Healthy volunteers who agreed to our study.
Key exclusion criteria Subject who is under 20 years old.
Pregnant
Subject who can not bear the restraint.
Subject who is affected on the cerebral blood flow or the cerebral metabolism by the encephalopathy.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Keisuke
Middle name
Last name Goto
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 hosyasen@nagoya-rehab.or.jp

Public contact
Name of contact person
1st name Keisuke
Middle name
Last name Goto
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 hosyasen@nagoya-rehab.or.jp

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

Funding Source
Organization Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization Other
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 none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 5
Results 
Between the two measurement methods, each of the CBF, CBV and CMRO2 showed strong correlation. Measured values at the seven measurement points of OEF and CMRO2 had differences over 10% between the two methods. Those differences might be originated from differences of the gas inhalation methods, measurements procedure, image reconstruction parameters and image analysis.
Without OEF, obtained regression equations could transform the measured values between the two measurement methods.
Results date posted
2019 Year 11 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Normal volunteers(3 male and 2 female, average age: 42.8 years)
Participant flow 
Obtained data from all 5 participants were analyzed.
Adverse events 
none
Outcome measures 
CBF:  y = 0.4933x + 24.453 (R2 = 0.629)
OEF:  y = 0.236x  + 38.032 (R2 = 0.1654)
CBV:  y = 0.8829x + 0.1211 (R2 = 0.9262)
CMRO2:y = 0.872x  + 1.5143 (R2 = 0.671)
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 05 Month 23 Day
Date of closure to data entry
2018 Year 05 Month 23 Day
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 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033276