UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008973 |
|---|---|
| Receipt number | R000010527 |
| Scientific Title | Comparison between pulmonary functional magnetic resonance imaging and computed tomography in patients with Chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2012/09/26 |
| Last modified on | 2018/03/30 09:41:38 |
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Basic information
Public title
Comparison between pulmonary functional magnetic resonance imaging and computed tomography in patients with Chronic obstructive pulmonary disease
Acronym
Comparison between pulmonary functional MRI and CT in COPD
Scientific Title
Comparison between pulmonary functional magnetic resonance imaging and computed tomography in patients with Chronic obstructive pulmonary disease
Scientific Title:Acronym
Comparison between pulmonary functional MRI and CT in COPD
Region
| Japan |
Condition
Condition
COPD(Chronic Obstructive Pulmonary Disease)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To visualize and analyze the relationship betweeen distribution of emphysema and ventilating air, O2 enhanced pulmonary MRI and chest CT scan will be performed in stable COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between the mean relative enhancement ratio from pulmonary O2 enhanced MRI and LAA% from chest CT.
Key secondary outcomes
Pulmonary function tests, questionaires of respiratory symptoms
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
Oxygen-enhanced MR images were obtained with inhaled oxygen
as the T1 contrast agent. The T1-weighted images were continually
collected by means of a respiratory synchronized.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinically stable COPD patients with age 40 or over
Key exclusion criteria
Patients with any other major pulmonary diseases such as bronchial asthma, interstitial pneumonia, lung cancer and respiratory tract infection according to chest CT and other laboratory findings.
Patients who are contraindicated for MRI.
Patients judged to be inappropriate by physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeo Muro |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Respiratory Medicine
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
smuro@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Muro |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Respiratory Medicine
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
Homepage URL
smuro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of health, labor and welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2012 | Year | 09 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 06 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 06 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 06 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 24 | Day |
Last modified on
| 2018 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010527
| 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 |
