UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029189 |
|---|---|
| Receipt number | 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 15:42:48 |
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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
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
a-iida@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033370
| Research Plan | |
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