UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison between pulmonary functional magnetic resonance imaging and computed tomography in patients with Chronic obstructive pulmonary disease
Title of the study (Brief title)	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	Shigeo Muro
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Respiratory Medicine
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3830
Email	smuro@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Shigeo Muro
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Respiratory Medicine
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3830
Homepage URL
Email	smuro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 10 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010527