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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007512
Receipt No. 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

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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 &#61656;Volunteers without psychological disorder.
&#61656;Age over 20 years
Key exclusion criteria &#61656;pregnant
&#61656;claustrophobia
&#61656;paced rhythm
&#61656;Prior diagnostic of pharmacological allergy
&#61656;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
Email

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
Email chtgkato@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine,
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008868

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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