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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007997
Receipt No. R000005741
Scientific Title CT ventilation mapping by single-breath stable xenon inhalation
Date of disclosure of the study information 2012/05/21
Last modified on 2012/05/21

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Basic information
Public title CT ventilation mapping by single-breath stable xenon inhalation
Acronym CT ventilation mapping by stable xenon inhalation
Scientific Title CT ventilation mapping by single-breath stable xenon inhalation
Scientific Title:Acronym CT ventilation mapping by stable xenon inhalation
Region
Japan

Condition
Condition lung cancer and other tumors
any condition that needs lung resection
Classification by specialty
Pneumology Chest surgery Radiology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validate appropriateness of CT ventilation map
Basic objectives2 Others
Basic objectives -Others To test accuracy of CT ventilation map for prediction of post-operative lung function compared with lung scanning
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes post-operative vital capacity and forced expiratory volume in 1 second
Key secondary outcomes

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
70 years-old >=
Gender Male and Female
Key inclusion criteria patients that need CT, lung scaning(perfusion and ventilation) and lung resection based on today's medical standards
Key exclusion criteria patients unable to undergo CT or lung scanning
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norinari Honda
Organization Saitama Medical Center
Saitama Medical University
Division name Radiology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama
TEL 81-49-228-3400
Email

Public contact
Name of contact person
1st name
Middle name
Last name Norinari Honda
Organization Saitama Medical Center
Division name Radiology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama
TEL 81-49-228-3400
Homepage URL
Email norihnd@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
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 埼玉医科大学総合医療センター

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 21 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 There was good correlation between predicted and measured VC, FVC, and FEV1
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
2010 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
2012 Year 05 Month 01 Day
Date trial data considered complete
2012 Year 05 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information To compare ventilation lung scanning and CT ventilation map by image inspection.
To compre predicted lung function (VC, FEV1) with postperative VC and FEV1.

Management information
Registered date
2012 Year 05 Month 21 Day
Last modified on
2012 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005741

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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