UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018534
Receipt number R000021447
Scientific Title A study to develop a technique for measuring restricted diffusion and water permeability in vivo with a clinical MRI scanner
Date of disclosure of the study information 2015/08/10
Last modified on 2016/02/04 17:32:24

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Basic information

Public title

A study to develop a technique for measuring restricted diffusion and water permeability in vivo with a clinical MRI scanner

Acronym

Measuring restricted diffusion and water permeability by clinical MRI

Scientific Title

A study to develop a technique for measuring restricted diffusion and water permeability in vivo with a clinical MRI scanner

Scientific Title:Acronym

Measuring restricted diffusion and water permeability by clinical MRI

Region

Japan


Condition

Condition

Healthy female volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop MRI scanning and image analyzing methods to measure restricted diffusion and water permeability in vivo.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Validity and reproducibility of the metrics. Robustness of the whole technique.

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

MRI scanning

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

40 years-old >

Gender

Female

Key inclusion criteria

Healthy female

Key exclusion criteria

1. history of severe systematic / CNS disease.
2. Drug and/or alcoholic abuse.
3. Not adaptable for MRI scanning (e.g. metallic devices, claustrophobia, nyctophobia)
4. Operator's decision as not suitable for this study.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiko Tachibana

Organization

National Institute of Radiological Sciences

Division name

Research Center for Charged Particle Therapy

Zip code


Address

4-9-1 Anagawa, Inage-ku, Chiba

TEL

043-251-2111

Email

ytachi@nirs.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuhiko Tachibana

Organization

National Institute of Radiological Sciences

Division name

Research center for Charged Particle Therapy

Zip code


Address

4-9-1 Anagawa, Inage-ku, Chiba

TEL

043-251-2111

Homepage URL


Email

ytachi@nirs.go.jp


Sponsor or person

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name



Funding Source

Organization

National institute of radiological sciences

Organization

Division

Category of Funding Organization

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

2015 Year 08 Month 10 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

Completed

Date of protocol fixation

2015 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 10 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

2015 Year 08 Month 04 Day

Last modified on

2016 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021447


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name