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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004588
Receipt No. R000005478
Scientific Title Development of digital adult head phantom for functional near infrared spectroscopy using multiple contrast-variant magnetic resonance images
Date of disclosure of the study information 2010/11/19
Last modified on 2014/05/27

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Basic information
Public title Development of digital adult head phantom for functional near infrared spectroscopy using multiple contrast-variant magnetic resonance images
Acronym Development of digital fNIRS phantom by multi-MRIs
Scientific Title Development of digital adult head phantom for functional near infrared spectroscopy using multiple contrast-variant magnetic resonance images
Scientific Title:Acronym Development of digital fNIRS phantom by multi-MRIs
Region
Japan

Condition
Condition Healthy Individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study aims at developing digital phantoms to estimate light propagation in adult head for near infrared spectroscopy by segmentation of multiple contrast-variant magnetic resonance images.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The distribution of optical properties in segmented MR images
Key secondary outcomes Positional accuracy of the marker between real and virtual space

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 3D position tracking digitizer
magnetic resonance imaging
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
60 years-old >
Gender Male and Female
Key inclusion criteria Healthy individuals who have the ability to provide informed consent.
Key exclusion criteria Individuals who have histories of psychiatric disorders including drug dependence and/or serious medical illness.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ito
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba
TEL 043-206-4702
Email hito@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kawaguchi
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba
TEL 043-206-4729
Homepage URL
Email kwgc@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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)

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

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2010 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 19 Day
Last modified on
2014 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005478

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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