UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006850 |
|---|---|
| Receipt number | R000008087 |
| Scientific Title | Evaluation of peripheral airway lesions using nonradioactive Xenon-enhanced CT |
| Date of disclosure of the study information | 2011/12/06 |
| Last modified on | 2017/07/17 18:11:52 |
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Basic information
Public title
Evaluation of peripheral airway lesions using nonradioactive Xenon-enhanced CT
Acronym
Evaluation of peripheral airway lesions using Xenon-enhanced CT
Scientific Title
Evaluation of peripheral airway lesions using nonradioactive Xenon-enhanced CT
Scientific Title:Acronym
Evaluation of peripheral airway lesions using Xenon-enhanced CT
Region
| Japan |
Condition
Condition
chronic obstructaive lung diseses,
pulmonary diseses with small-airway obstruction
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical usefulness of Xenon-enhanced CT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Correlation between pulmonary function tests and images of ventilation with Xenon-enhanced CT
2. Evaluation of effectiveness of bronchodilator or inhaled steroids in patients with obstructive pulmonary diseases using Xenon-enhanced CT
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CT with inhalation of nonradioactive Xenon
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
chronic obstructaive lung diseses
pulmonary diseses with small-airway obstruction
Key exclusion criteria
patients under 20 years old
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutsugu Uematsu |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Pulmonary Medicine
Zip code
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
+81-49-228-3461
kuematsu@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kyoyama |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Pulmonary Medicine
Zip code
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
+81-49-228-3461
Homepage URL
kuematsu@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, 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
| 2011 | Year | 12 | Month | 06 | 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
| 2011 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 06 | Day |
Last modified on
| 2017 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008087
