UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007512 |
|---|---|
| Receipt number | R000008868 |
| Scientific Title | Development of diagnostic equipment for dementia with quantification of oxygen concentration in the blood using near infrared spectroscopy (NIRS) |
| Date of disclosure of the study information | 2012/03/15 |
| Last modified on | 2012/03/15 11:49:03 |
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Basic information
Public title
Development of diagnostic equipment for dementia with quantification of oxygen concentration in the blood using near infrared spectroscopy (NIRS)
Acronym
Development of diagnostic equipment for dementia using near infrared spectroscopy (NIRS)
Scientific Title
Development of diagnostic equipment for dementia with quantification of oxygen concentration in the blood using near infrared spectroscopy (NIRS)
Scientific Title:Acronym
Development of diagnostic equipment for dementia using near infrared spectroscopy (NIRS)
Region
| Japan |
Condition
Condition
normal volunteers
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a diagnostic equipment for dementia with quantification of oxygen concentration in the blood using near infrared spectroscopy (NIRS).
NIRS sensors are attached on the forehead of the subject. The equipment enables the quantification of the blood concentration in the frontal lobe on the cerebral cortex non-invasively.
The quantitative estimates are evaluated with 15O-CO PET which yields precise quantitative images of the hemoglobin in the brain.
Subjects of this study are ten healthy subjects with no physiologic disorder. Quantified blood volume using NIRS and 15O-CO PET will be compared, reliability of the NIRS sensor will be evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantification of hemoglobin concentration in the bilateral frontal lobe in the brain using NIRS censors.
Imaging of hemoglobin distribution in the brain using 15O-CO and PET.
Biochemical marcers in the venous blood.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Volunteers without psychological disorder.
Age over 20 years
Key exclusion criteria
pregnant
claustrophobia
paced rhythm
Prior diagnostic of pharmacological allergy
Any person who is not regarded as a suitable subject for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagara Tamaki, M.D., Ph.D, |
Organization
Hokkaido University Graduate School of Medicine,
Division name
Department of nuclear medicine
Zip code
Address
Kita-15, Nishi-7, Kita-Ku, Sapporo,
TEL
011-706-5152
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chietsugu Katoh, M.D., Ph.D, |
Organization
Hokkaido University Graduate School of Medicine,
Division name
Faculty of health sciences
Zip code
Address
Kita-12, Nishi-5, Kita-Ku, Sapporo,
TEL
011-706-3336
Homepage URL
chtgkato@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
Ministry of economy, trade and industry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shizuoka university, faculty of engineering
Astem Co. Ltd.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 15 | 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
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Quantified blood volume using NIRS and 15O-CO PET will be compared, reliability of the NIRS sensor will be evaluated.
Management information
Registered date
| 2012 | Year | 03 | Month | 15 | Day |
Last modified on
| 2012 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008868
