UMIN-CTR Clinical Trial

Basic information
Public title	Development and evaluation of minimally invasive and Dynamic digital radiography
Acronym	Development and evaluation of minimally invasive and Dynamic digital radiography
Scientific Title	Development and evaluation of minimally invasive and Dynamic digital radiography
Scientific Title:Acronym	Development and evaluation of minimally invasive and Dynamic digital radiography
Region	Japan

Condition
Condition	patients with respiratory diseases
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of dynamic digital radiography in evaluating respiratory function.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Lung area respiration rate and lung volume fraction obtained from dynamic digital radiography
Key secondary outcomes	Lung area respiration change rate and health-related QOL obtained from dynamic digital radiography, walking distance for 6 minutes

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	Sequential chest X-ray images were obtained during respiration with use of a dynamic FPD imaging system (Test Model, Konica Minolta, Inc., Tokyo, Japan), consisting of an indirect-conversion FPD (PaxScan, 4343CB, Varex Imaging Corporation, Salt Lake City, UT, USA), and X-ray generator/tube capable of pulsed irradiation (DHF-155H II/UH-6QC-07E, Hitachi, Ltd.). To be a reliable diagnostic tool, the system must have a high homogeneity and uniformity in X-ray pulses. Except for the breathing pattern, imaging is performed in the same way as a conventional chest examination (i.e., the standing position and posteroanterior [PA] direction). For an accurate evaluation of pulmonary function, it is crucial to include one respiratory cycle within a limited amount of time with good reproducibility. Therefore, it is recommended to use an automatic voice system and pre-train patients. The total patient dose is adjustable by changes in the imaging time, imaging rate, and source-to-image distance (SID), and can be less than the dose limit for two projections (PA + LA) recommended by the International Atomic Energy Agency (IAEA). In this study the exposures were obtained using the following parameters: 100 kV; 50 mA; 2.5 ms; 15 frames per second; and 2.0 m from the SID. The entrance surface dose to the detector is approximately 0.21 mSv in 14 s.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with respiratory disease
Key exclusion criteria	Patients who cannot perform respiratory function tests.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name Kasahara
Organization	Kanazawa university hospital
Division name	respiratory medicine
Zip code	9208641
Address	13-1 Takaramachi Kanazawa, Ishikawa
TEL	+81762652757
Email	k-kasa@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Noriyuki Middle name Last name Ohkura
Organization	Kanazawa university hospital
Division name	respiratory medicine
Zip code	9208641
Address	13-1 Takaramachi Kanazawa, Ishikawa
TEL	+81762652757
Homepage URL
Email	n-ohkura@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa university hospital
Institute
Department

Funding Source
Organization	Konica Minolta, Inc. (Tokyo, Japan)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Medical Ethics Committee of Kanazawa University
Address	13-1 Takaramachi Kanazawa, Ishikawa
Tel	076-265-2110
Email	rinri@adm.kanazawa-u.ac.jp

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	2020 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2015 Year 05 Month 01 Day
Date of IRB	2015 Year 06 Month 10 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 08 Month 31 Day
Date analysis concluded	2021 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 03 Month 05 Day
Last modified on	2021 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045085