UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006934
Receipt number R000008195
Scientific Title Analysis of peripheral lung by super resolution CT in various lung diseases
Date of disclosure of the study information 2012/01/01
Last modified on 2011/12/22 08:54:40

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Basic information

Public title

Analysis of peripheral lung by super resolution CT in various lung diseases

Acronym

Lung images by super resolution CT

Scientific Title

Analysis of peripheral lung by super resolution CT in various lung diseases

Scientific Title:Acronym

Lung images by super resolution CT

Region

Japan


Condition

Condition

lung diseases

Classification by specialty

Medicine in general Pneumology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Quantitative analysis with more than 1mm acurecy on various lung diseases.

Basic objectives2

Others

Basic objectives -Others

Quatitative analysis of peripheral airways in patients with asthma or chronic obstructive lung diseases.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation of peripheral lung.

Key secondary outcomes

Analysis of confident range of CT resolution.


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who requires CT test for the diagnosis of chest diseases or health check.

Key exclusion criteria

Patients under 20 years old.
Patients who do not want take CT examination.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyoshi Kurashima

Organization

Saitama cardiovascular and respiratory center

Division name

respiratory medicine

Zip code


Address

1696Itai, Kumagaya city, Saitama

TEL

048-536-9900

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuyoshi Kurashima

Organization

Saitama cardiovascular and respiratory center

Division name

respiratory medicine

Zip code


Address

1696Itai, Kumagaya city, Saitama

TEL

048-536-9900

Homepage URL


Email



Sponsor or person

Institute

Saitama cardiovascular and respiratory center

Institute

Department

Personal name



Funding Source

Organization

Saitama cardiovascular and respiratory center

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


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 01 Month 01 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

Preinitiation

Date of protocol fixation

2011 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2012 Year 12 Month 01 Day

Date of closure to data entry

2012 Year 12 Month 01 Day

Date trial data considered complete

2012 Year 12 Month 01 Day

Date analysis concluded

2012 Year 12 Month 01 Day


Other

Other related information

Verification of CT resolution using phantom with known diameters.
Analysis of airway diameter and airway wall thickness.


Management information

Registered date

2011 Year 12 Month 22 Day

Last modified on

2011 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008195


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name