UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039718
Receipt number R000045085
Scientific Title Development and evaluation of minimally invasive and Dynamic digital radiography
Date of disclosure of the study information 2020/04/01
Last modified on 2021/09/05 19:14:35

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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 or person

Institute

Kanazawa university hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045085


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name