UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004588
Receipt number 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 15:25:23

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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 or person

Institute

National Institute of Radiological Sciences

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)



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

Value
https://center6.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