UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007997 |
|---|---|
| Receipt number | 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 14:22:52 |
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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
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
norihnd@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005741
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
