UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of efficacy of quantitate analysis using paired expiratory and inspiratory CT for diagnosis of cystic lung diseases
Title of the study (Brief title)	quantitative analysis of expiratory and inspiratory CT for cystic lung diseases
Region	Japan

Condition
Condition	cystic lung disease
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the usefulness of quantitative analysis using paired inspiratory and expiratory CT for diagnosis of cystic lung diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	final diagnosis (pathological, geneticl or clinical diagnosis)
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	Self control
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 examination
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	Patients who were suspected for cystic lung disease by medical imagings.
Key exclusion criteria	1. patients accompanied by pneumothorax 2. patients with noticeable lung features besides cystic changes. 3. cystic lesion to entire lung volume ratio is supposed to be greater than 50%
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuhiro Suzuki
Organization	Juntendo University
Division name	Department of Radiology
Address	3-1-3, hongo, bunkyo-ku, Tokyo
TEL	03-3813-31111
Email	ka-suzz@juntendo.ac.jp

Public contact
Name of contact person	Miyamoto / Ishiguro
Organization	Juntendo University
Division name	Department of Radiology
Address	3-1-3, hongo, bunkyo-ku, Tokyo
TEL	03-3813-31111
Homepage URL
Email	kenkyu5858@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	2017 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 28 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2019 Year 02 Month 27 Day
Date of closure to data entry	2019 Year 02 Month 27 Day
Date trial data considered complete	2019 Year 02 Month 27 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 12 Day
Last modified on	2019 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031312