Chronic Obstructive Pulmonary Disease (COPD)NCT06653413
Exploring the Diagnostic Performance of Dynamic Chest Radiology in Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The prevalence of chronic obstructive pulmonary disease (COPD) is on the rise, leading to an increasing economic and social burden. Currently, the diagnosis and staging of COPD heavily rely on pulmonary function testing. However, limitations such as patient cooperation and comorbidities can hinder accurate diagnosis. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective clinical study of COPD patients and normal subjects in our hospital. This study has been approved by the hospital Ethics Committee and the patient's informed consent has been obtained (approval number: MR-44-24-016286).
Who may be able to join
- COPD group: (1) Patients ≥30 years of age and ≤ 80 years of age who meet the 2023 GOLD Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease, i.e., anyone who complains of dyspnea, chronic cough or sputum, a history of recurrent lower respiratory infection and/or exposure to disease risk factors, Moreover, pulmonary function examination indicated that FEV1/FVC <0.7 after bronchodilator was used to confirm COPD. FEV1%pred is used to determine the severity of airflow obstruction: Grade GOLD 1 (mild) : FEV1%pred ≥ 80%, Grade GOLD2 (moderate) : 50% ≤ FEV1%pred < 80%, grade GOLD3 (severe) : 30% ≤ FEV1%pred < 50%, GOLD4 grade (extremely severe) : FEV1%pred < 30%; (2) Signing informed consent; (3) Can cooperate with the completion of dynamic chest X-ray (complete dynamic chest X-ray positioning for 20 seconds, during which calm breathing, hard breathing, can hold breath for at least 7 seconds).
- Normal Group: (1) Age ≥30 years old and ≤ 80 years old; (2) Normal pulmonary ventilation function; (3) Exclude chronic airway diseases (such as COPD, asthma, bronchiectasis, etc.); (4) Signing informed consent; (5) Can cooperate with the completion of dynamic chest X-ray (complete dynamic chest X-ray positioning for 20 seconds, during which calm breathing, hard breathing, can hold breath for at least 7 seconds).
Who cannot join
- COPD group: (1) A history of cancer, lung surgery, other lung diseases (such as pneumonia, active tuberculosis, severe bronchiectasis); (2) Combined with muscle-related diseases such as myasthenia gravis or wasting diseases that affect muscle mass such as severe hyperthyroidism and advanced malignant diseases; (3) Pregnant or lactating women; (4) Significant radiation exposure (dose >10mSv) was involved in the 12 months prior to study participation. Normal Group: (1) Have acute or chronic cardiopulmonary disease in the past, abnormal lung physical examination and lung imaging examination in the past, and have a history of infectious diseases within the past 1 month; (2) Pregnant or lactating women; (3) Significant radiation exposure (dose >10mSv) was involved in the 12 months prior to study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Locations
Guangzhou, Guangdong
Dong Yu, PhD student, +86 15625868995, 15625868995@163.com
Laiyu Liu, professor, +86 13632102245, liulaiyu@sina.com
About this study
The prevalence of chronic obstructive pulmonary disease (COPD) is on the rise, leading to an increasing economic and social burden. Currently, the diagnosis and staging of COPD heavily rely on pulmonary function testing. However, limitations such as patient cooperation and comorbidities can hinder accurate diagnosis. In situations like a respiratory pandemic, pulmonary function testing may not be feasible. Dynamic chest radiography has emerged as a promising area of research due to its quick procedure, high patient cooperation, low risk, minimal radiation exposure, and reduced direct contact. Recent clinical studies have started to explore the relationship between dynamic chest X-ray measurements and lung function parameters. However, there is a noticeable scarcity of research focusing on the use of dynamic chest X-ray in aiding the diagnosis of COPD, particularly in Chinese populations where cohort data is lacking. Consequently, there is a pressing need to investigate the correlation between various dynamic chest radiograph parameters and lung function indicators, as well as their potential diagnostic value in COPD.
Read the detailed description
The incidence and mortality of COPD continue to rise in China, but the awareness level of patients with this disease is not enough. Due to the low treatment compliance, it is not possible to conduct regular review, resulting in difficult to effectively control the disease, acute aggravation of repeated attacks, and then bring a heavy economic burden to society. Therefore, in order to reduce the occurrence of acute exacerbations and improve the quality of life of patients, COPD patients need to strengthen their awareness of the disease, improve treatment compliance, and undergo regular review.
The severity of COPD is diagnosed and assessed mainly by pulmonary function examination. Lung capacity, lung volume, and lung diffusion capacity can be determined by a lung function test to assess the health of lung function. Airflow limitation is an important diagnostic criterion, and the key indicator for determining airflow limitation is the one-second rate (FEV1/FVC) less than 0.7 after inhalation of bronchodilators. The percentage of measured forced expiratory volume in the first second to the estimated value (FEV1%pred) was the primary parameter for assessing the severity of COPD. However, some literature has pointed out that FEV1%pred does not fully reflect the clinical symptoms and quality of life of patients. Although pulmonary function examination is of great significance in evaluating patients' lung conditions, it can not fully evaluate small airway lesions and lung parenchymal injury, and there are problems of non-standard and inaccurate data. Due to the low rate of pulmonary function examination, it can not fully represent the lung condition of patients, and it is still necessary to combine other examination methods to comprehensively evaluate the lung health status of patients.
Dynamic Chest Radiography (DCR) is a real-time X-ray imaging system that takes continuous images of a moving chest, usually in 10 to 20 seconds, and is a fast, well-tolerated, and simple chest radiography technique. Measurements of diaphragm movement, lung area, and lung perfusion can provide multiple examination information for COPD patients and supplement baseline deficiencies in critically ill patients.
The purpose of this study was to evaluate the dynamic chest radiography of COPD patients based on Chinese population, analyze the characteristics of dynamic chest radiography of COPD patients, and study the correlation between chest radiography and lung function. To study the value of dynamic chest radiography in diagnosing COPD. To investigate the role of dynamic chest radiography in evaluating the severity of airflow restriction in COPD and predicting the clinical outcome of COPD. Through multidimensional dynamic assessment of patients, dynamic chest radiography can help doctors more accurately diagnose patients' conditions, and timely interventional treatment, so as to reduce the occurrence of acute exacerbations, delay the risk of disease progression, and improve patients' quality of life.
- Keywords
- Chronic obstructive pulmonary disease, Dynamic chest radiology, Pulmonary function test, Diagnosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD group | any patient who complains of dyspnea, chronic cough or sputum, a history of recurrent lower respiratory infection and/or a history of exposure to disease risk factors, Pulmonary function examination indicated that FEV1/FVC <0.7 after bronchodilator was used to confirm COPD. | |
| normal group | No acute or chronic cardiopulmonary disease in the past, no abnormal lung physical examination and lung imaging examination in the past month, no history of infectious diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic chest radiographs were used to measure diaphragm movement, lung field area and lung field area change rate
Dynamic chest radiographs of patients with COPD were analyzed and their correlation with lung function was studied. To study the value of dynamic chest radiography in diagnosing COPD. To investigate the role of dynamic chest radiography in evaluating the severity of airflow restriction in COPD and predicting the clinical outcome of COPD.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Jan 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital, Qingyuan People's Hospital
- Responsible party
- Sponsor
- Investigators
- Laiyu Liu, professor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653413
- Sponsor's protocol ID
- NFEC-2024-158
- Other IDs
- 32470763
- Status last verified
- Jul 2026
- First submitted
- 20 Oct 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu D, Xie W, Guo Y, Zhu X, Liang W, Li M, Mao Y, He Z, Wu J, Yuan L, Huang W, Huang J, He S, Zhou Z, Huang X, Zhan Y, Dong H, Cai S, Cui ZK, Qin G, Liu L. Dynamic Chest Radiography as an Alternative to Pulmonary Function Tests for Chronic Obstructive Pulmonary Disease. Radiology. 2025 Dec;317(3):e251296. doi: 10.1148/radiol.251296.
PubMed 41400467
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Diagnostic Performance of Dynamic Chest Radiology in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06653413
- Acronym / sponsor ID
- NFEC-2024-158
- Keywords
- Chronic obstructive pulmonary disease, Dynamic chest radiology, Pulmonary function test, Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital, Qingyuan People's Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of chronic obstructive pulmonary disease (COPD) is on the rise, leading to an increasing economic and social burden. Currently, the diagnosis and staging of COPD heavily rely on pulmonary function testing. However, limitations such as patient cooperation and comorbidities can hinder accurate diagnosis. In situations like a respiratory pandemic, pulmonary function testing may not be feasible. Dynamic chest radiography has emerged as a promising area of research due to its quick procedure, high patient cooperation, low risk, minimal radiation exposure, and reduced direct contact. Recent clinical studies have started to explore the relationship between dynamic chest X-ray measurements and lung function parameters. However, there is a noticeable scarcity of research focusing on the use of dynamic chest X-ray in aiding the diagnosis of COPD, particularly in Chinese populations where cohort data is lacking. Consequently, there is a pressing need to investigate the correlation between various dynamic chest radiograph parameters and lung function indicators, as well as their potential diagnostic value in COPD.
Detailed description
The incidence and mortality of COPD continue to rise in China, but the awareness level of patients with this disease is not enough. Due to the low treatment compliance, it is not possible to conduct regular review, resulting in difficult to effectively control the disease, acute aggravation of repeated attacks, and then bring a heavy economic burden to society. Therefore, in order to reduce the occurrence of acute exacerbations and improve the quality of life of patients, COPD patients need to strengthen their awareness of the disease, improve treatment compliance, and undergo regular review.
The severity of COPD is diagnosed and assessed mainly by pulmonary function examination. Lung capacity, lung volume, and lung diffusion capacity can be determined by a lung function test to assess the health of lung function. Airflow limitation is an important diagnostic criterion, and the key indicator for determining airflow limitation is the one-second rate (FEV1/FVC) less than 0.7 after inhalation of bronchodilators. The percentage of measured forced expiratory volume in the first second to the estimated value (FEV1%pred) was the primary parameter for assessing the severity of COPD. However, some literature has pointed out that FEV1%pred does not fully reflect the clinical symptoms and quality of life of patients. Although pulmonary function examination is of great significance in evaluating patients' lung conditions, it can not fully evaluate small airway lesions and lung parenchymal injury, and there are problems of non-standard and inaccurate data. Due to the low rate of pulmonary function examination, it can not fully represent the lung condition of patients, and it is still necessary to combine other examination methods to comprehensively evaluate the lung health status of patients.
Dynamic Chest Radiography (DCR) is a real-time X-ray imaging system that takes continuous images of a moving chest, usually in 10 to 20 seconds, and is a fast, well-tolerated, and simple chest radiography technique. Measurements of diaphragm movement, lung area, and lung perfusion can provide multiple examination information for COPD patients and supplement baseline deficiencies in critically ill patients.
The purpose of this study was to evaluate the dynamic chest radiography of COPD patients based on Chinese population, analyze the characteristics of dynamic chest radiography of COPD patients, and study the correlation between chest radiography and lung function. To study the value of dynamic chest radiography in diagnosing COPD. To investigate the role of dynamic chest radiography in evaluating the severity of airflow restriction in COPD and predicting the clinical outcome of COPD. Through multidimensional dynamic assessment of patients, dynamic chest radiography can help doctors more accurately diagnose patients' conditions, and timely interventional treatment, so as to reduce the occurrence of acute exacerbations, delay the risk of disease progression, and improve patients' quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD group | – | –any patient who complains of dyspnea, chronic cough or sputum, a history of recurrent lower respiratory infection and/or a history of exposure to disease risk factors, Pulmonary function examination indicated that FEV1/FVC <0.7 after bronchodilator was used to confirm COPD. |
| normal group | – | –No acute or chronic cardiopulmonary disease in the past, no abnormal lung physical examination and lung imaging examination in the past month, no history of infectious diseases. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective clinical study of COPD patients and normal subjects in our hospital. This study has been approved by the hospital Ethics Committee and the patient's informed consent has been obtained (approval number: MR-44-24-016286).
Key inclusion criteria (2 listed)
- COPD group: (1) Patients ≥30 years of age and ≤ 80 years of age who meet the 2023 GOLD Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease, i.e., anyone who complains of dyspnea, chronic cough or sputum, a history of recurrent lower respiratory infection and/or exposure to disease risk factors, Moreover, pulmonary function examination indicated that FEV1/FVC <0.7 after bronchodilator was used to confirm COPD. FEV1%pred is used to determine the severity of airflow obstruction: Grade GOLD 1 (mild) : FEV1%pred ≥ 80%, Grade GOLD2 (moderate) : 50% ≤ FEV1%pred < 80%, grade GOLD3 (severe) : 30% ≤ FEV1%pred < 50%, GOLD4 grade (extremely severe) : FEV1%pred < 30%; (2) Signing informed consent; (3) Can cooperate with the completion of dynamic chest X-ray (complete dynamic chest X-ray positioning for 20 seconds, during which calm breathing, hard breathing, can hold breath for at least 7 seconds).
- Normal Group: (1) Age ≥30 years old and ≤ 80 years old; (2) Normal pulmonary ventilation function; (3) Exclude chronic airway diseases (such as COPD, asthma, bronchiectasis, etc.); (4) Signing informed consent; (5) Can cooperate with the completion of dynamic chest X-ray (complete dynamic chest X-ray positioning for 20 seconds, during which calm breathing, hard breathing, can hold breath for at least 7 seconds).
Key exclusion criteria (1 listed)
- COPD group: (1) A history of cancer, lung surgery, other lung diseases (such as pneumonia, active tuberculosis, severe bronchiectasis); (2) Combined with muscle-related diseases such as myasthenia gravis or wasting diseases that affect muscle mass such as severe hyperthyroidism and advanced malignant diseases; (3) Pregnant or lactating women; (4) Significant radiation exposure (dose >10mSv) was involved in the 12 months prior to study participation. Normal Group: (1) Have acute or chronic cardiopulmonary disease in the past, abnormal lung physical examination and lung imaging examination in the past, and have a history of infectious diseases within the past 1 month; (2) Pregnant or lactating women; (3) Significant radiation exposure (dose >10mSv) was involved in the 12 months prior to study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic chest radiographs were used to measure diaphragm movement, lung field area and lung field area change rate
Time frame: 3 year
Dynamic chest radiographs of patients with COPD were analyzed and their correlation with lung function was studied. To study the value of dynamic chest radiography in diagnosing COPD. To investigate the role of dynamic chest radiography in evaluating the severity of airflow restriction in COPD and predicting the clinical outcome of COPD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Derived from this study: PubMed 41400467Yu D, Xie W, Guo Y, Zhu X, Liang W, Li M, Mao Y, He Z, Wu J, Yuan L, Huang W, Huang J, He S, Zhou Z, Huang X, Zhan Y, Dong H, Cai S, Cui ZK, Qin G, Liu L. Dynamic Chest Radiography as an Alternative to Pulmonary Function Tests for Chronic Obstructive Pulmonary Disease. Radiology. 2025 Dec;317(3):e251296. doi: 10.1148/radiol.251296.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laiyu Liu, professor study chair
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laiyu Liu, professor (+86 13632102245, liulaiyu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic chest radiographs were used to measure diaphragm movement, lung field area and lung field area change rate (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06653413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.