UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012523 |
|---|---|
| Receipt number | R000014656 |
| Scientific Title | Xenon ventilation imaging using dual-energy computed tomography in combined pulmonary fibrosis and emphysema |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2016/06/04 12:23:38 |
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Basic information
Public title
Xenon ventilation imaging using dual-energy computed tomography in combined pulmonary fibrosis and emphysema
Acronym
Xe-DECT in CPFE
Scientific Title
Xenon ventilation imaging using dual-energy computed tomography in combined pulmonary fibrosis and emphysema
Scientific Title:Acronym
Xe-DECT in CPFE
Region
| Japan |
Condition
Condition
Emphysematous chronic obstructive pulmonary disease, Chronic fibrosing interstitial pneumonia, Combined pulmonary fibrosis and emphysema
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to assess the feasibility of xenon ventilation computed tomography (CT) in the visual and quantitative analysis of combined pulmonary fibrosis and emphysema (CPFE)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy and safety of Xe-DECT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
the feasibility of xenon ventilation computed tomography (CT) in the visual and quantitative analysis of combined pulmonary fibrosis and emphysema (CPFE)
Interventions/Control_2
Comparison between CPFE and emphysematous COPD
Interventions/Control_3
Comparison between CPFE and chronic fibrosing interstitial pneumonia
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age of 40 <=, 85>
2) Sex: male and female
3) Patients: hospital patinets and outpatinets
4) Accepted informed consents
5) Clinically suspected or confirmed chronic fibrosing interstitial pneumonia, emphysematous COPD, and CPFE
Key exclusion criteria
1) unstable clinical condition and complication of severe underlying diseases
2) unable to examine pulmonary function tests
3) history of prior reaction to iodinated contrast media
4) serum creatinine value >= 2mg/dl
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakae Homma |
Organization
Toho University Omori Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
+81-3-3762-4151
sahomma@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keishi Sugino |
Organization
Toho University Omori Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
+81-3-3762-4151
Homepage URL
ks142129_ikusou@ybb.ne.jp
Sponsor or person
Institute
Toho University Omori Medical Center,Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 09 | 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
| 2012 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 09 | Day |
Last modified on
| 2016 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014656
