NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042220018

Registered date:19/05/2022

New pulmonary function assessment using chest X-ray dynamic digital radiography

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedChronic obstructive pulmonary disease (COPD), In terstitial lung disease (ILD)
Date of first enrollment21/06/2022
Target sample size160
Countries of recruitment
Study typeInterventional
Intervention(s)Pulmonary function test and chest X-ray dynamic digital radiography are performed on the subject at visit 1. The diagnostic imaging workstation Konica Minolta DI-X1 will be used to analyze lung field area, lung field area change rate, diaphragm change, lung ventilation mapping, and lung blood flow.

Outcome(s)

Primary OutcomePrimary endpoint 1: Diagnosis of obstructive ventilatory disorder (FEV1/FVC <0.7) by chest X-ray dynamic digital radiography. Primary endpoint 2: Diagnosis of restrictive ventilatory disorder (predictive vital capacity <80%) by chest X-ray dynamic digital radiography.
Secondary Outcome1) Detection of mixed ventilatory impairment (1 sec/lung volume <0.7 and predicted lung volume <80%) 2) Dynamic parameters (maximum lung field area, tracheal stenosis rate, lung field area change rate) using chest X-ray dynamic analysis of frontal + lateral chest X-ray images 3) Respiratory function (VC, FVC) 4) Dyspnea grade (mMRC grade) 5) Health-related quality of life (CAT score) 6) Lung fields of ventilation analysis images generated from X-ray dynamic images 6) Analysis signal values for the entire lung field and upper, middle and lower lung fields (pulmonary ventilation mapping image) (7) Analyzed signal values for the entire lung fields and the upper, middle, and lower lung fields in the blood flow analysis image generated from the X-ray dynamic image (pulmonary blood flow mapping image) Translated with www.DeepL.com/Translator (free version)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients who meet all of the following conditions. 1) Patients who visit the Department of Respiratory Surgery or the Department of Respiratory Medicine at our hospital and are classified by respiratory function tests as 1) COPD patients, 2) ILD patients, 3) patients with mixed ventilation disorder, or 4) patients with normal respiratory function. 2) Age 20 years or older at the time of obtaining written consent. 3) Able to hold a standing position during radiography. 4) Able to take deep breaths and hold breaths according to the respiratory protocol during radiography. 5) Written consent has been obtained from the patient himself/herself after sufficient informed consent for participation in the clinical study.
Exclude criteriaPatients who meet one or more of the following conditions. 1) The patient is pregnant or may become pregnant. 2) Patients who are judged by the principal investigator or sub-investigator to be unsuitable as research subjects.

Related Information

Contact

Public contact
Name Ohkura Noriyuki
Address 13-1 Takaramachi, Kanazawa, Ishikawa Ishikawa Japan 920-8641
Telephone +81-76-265-2757
E-mail n-ohkura@med.kanazawa-u.ac.jp
Affiliation Kanazawa University Hospital
Scientific contact
Name Noriyuki Ohkura
Address 13-1 Takaramachi, Kanazawa, Ishikawa Ishikawa Japan 920-8641
Telephone +81-76-265-2757
E-mail n-ohkura@med.kanazawa-u.ac.jp
Affiliation Kanazawa University Hospital