UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007253
Receipt number R000008555
Scientific Title Evaluation for clinical utility of Advanced MR imaging
Date of disclosure of the study information 2012/02/10
Last modified on 2014/02/18 10:25:09

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Basic information

Public title

Evaluation for clinical utility of Advanced MR imaging

Acronym

Clinical utility of Advanced MRI

Scientific Title

Evaluation for clinical utility of Advanced MR imaging

Scientific Title:Acronym

Clinical utility of Advanced MRI

Region

Japan


Condition

Condition

central nervous system disease

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

For the patient that CNS disease is suspected by a morphological diagnosis by MRI, we perform advanced MRI and evaluate for clinical utility.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We compare blood flow by advanced MRI with metabolic function by PET/SPECT, and review it about evaluation for CNS disease by advanced MRI.

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

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

MRI

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patient that a central nervous system disease is suspected by a morphological diagnosis by MRI

Key exclusion criteria

The patient who has metal such as pacemaker in the body, and cannot perform MRI examination

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya Yamamoto

Organization

University Of Fukui

Division name

Department of Radiology

Zip code


Address

23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

TEL

0776613111

Email

yamatatu@jichi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Yamamoto

Organization

University Of Fukui

Division name

Department of Radiology

Zip code


Address

23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

TEL

0776-61-3111

Homepage URL


Email

yamatatu@jichi.ac.jp


Sponsor or person

Institute

University Of Fukui

Institute

Department

Personal name



Funding Source

Organization

University Of Fukui

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

2012 Year 02 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

Enrolling by invitation

Date of protocol fixation

2010 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 08 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

2012 Year 02 Month 09 Day

Last modified on

2014 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008555


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name