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

Clinical study on a new pulmonary function assessment using chest X-ray dynamic digital radiography

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042220018
Enrollment
160
Registered
2022-05-19
Start date
2022-06-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD), In terstitial lung disease (ILD)

Interventions

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
dynamic digital chest radiography

Sponsors

Ohkura Noriyuki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients 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.

Exclusion criteria

Exclusion criteria: Patients 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.

Design outcomes

Primary

MeasureTime frame
Primary 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

MeasureTime frame
1) 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)

Contacts

Public ContactOhkura Noriyuki

Kanazawa University Hospital

n-ohkura@med.kanazawa-u.ac.jp+81-76-265-2757

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026