UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Xenon ventilation imaging using dual-energy computed tomography in combined pulmonary fibrosis and emphysema
Title of the study (Brief title)	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

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Sakae Homma
Organization	Toho University Omori Medical Center
Division name	Department of Respiratory Medicine
Address	6-11-1, Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL	+81-3-3762-4151
Email	sahomma@med.toho-u.ac.jp

Public contact
Name of contact person	Keishi Sugino
Organization	Toho University Omori Medical Center
Division name	Department of Respiratory Medicine
Address	6-11-1, Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL	+81-3-3762-4151
Homepage URL
Email	ks142129_ikusou@ybb.ne.jp

Sponsor
Institute	Toho University Omori Medical Center,Department of Respiratory Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014656