UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029191 |
|---|---|
| Receipt number | 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 13:35:22 |
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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
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
hosyasen@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033276
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