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Volumetric HRCT in Stable COPD Patients.

2026年9月2日 更新者：Mansoura University

The Role of Volumetric High-Resolution Computed Tomography (HRCT) of the Chest in the Assessment of Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)

This study evaluates the role of volumetric high-resolution computed tomography (HRCT) of the chest in assessing patients with stable chronic obstructive pulmonary disease (COPD). COPD is a heterogeneous lung condition characterized by chronic pulmonary symptoms, structural airway/alveolar changes, and progressive airflow limitation. While spirometry provides a global assessment of lung function, it cannot localize or fully characterize specific structural abnormalities. Volumetric HRCT allows for detailed, quantitative imaging of lung parenchyma, emphysema extent, air trapping, and airway wall thickness. The primary objective of this cross-sectional observational study is to quantify emphysema, air trapping, and bronchial wall thickness in patients with stable COPD and to evaluate the relationship between these volumetric HRCT findings and clinical measures of disease severity. By identifying objective imaging parameters, this study aims to improve patient evaluation, disease staging, and clinical management.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Background and Rationale:

Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent respiratory symptoms (such as dyspnea, cough, and sputum production) resulting from airway and/or alveolar abnormalities that cause progressive airflow obstruction. While irreversible airflow obstruction (post-bronchodilator FEV1/FVC < 0.70) measured by spirometry confirms the diagnosis, global spirometric tests lack the spatial resolution required to assess regional parenchymal destruction, emphysema distribution, or peripheral air trapping. Volumetric High-Resolution Computed Tomography (HRCT) enables detailed, three-dimensional quantitative assessment of lung parenchyma and structural alterations in COPD.

Study Objectives:

To quantify emphysema extent, air trapping, and airway wall thickness using volumetric HRCT.

To assess the relationship between quantitative volumetric HRCT findings and clinical measures of COPD severity.

Methods and Procedures:

This cross-sectional observational study is conducted at Mansoura University Hospital (smoking clinic and chest disease general clinic) under ethics approval code MS.25.02.3101. Enrolled participants include patients with stable COPD diagnosed according to GOLD guidelines.

All participants undergo the following assessments:

Clinical Evaluation: Comprehensive history taking (symptoms, smoking status), physical examination, and mMRC Dyspnea Scale grading.

Pulmonary Function Testing & Lung Volumes: Spirometry (FEV1, FVC, FEV1/FVC, MMEF), 6-Minute Walk Test (6MWT), and lung volume measurements (RV, TLC, RV/TLC%).

Laboratory Tests: Complete Blood Count (CBC) with calculation of Neutrophil-to-Lymphocyte Ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR), and Arterial Blood Gas (ABG) analysis.

HRCT Imaging Protocol: Multidetector HRCT (minimum 64-slice, ≤1,5 mm slice thickness, 512x512 matrix) performed during full inspiratory breath-hold (with optional expiratory scanning for air trapping evaluation). Dedicated high-resolution algorithms and window settings are applied to quantify parenchymal and bronchial changes.

nd bronchial changes.

研究类型

观察性的

注册 (实际的)

75

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 埃及
    • Dakahlia Governorate
      • Al Mansurah、Dakahlia Governorate、埃及、35516
        • Mansoura University Hospital (Chest Disease Department)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

Patients attending the smoking clinic and chest disease general clinic at Mansoura University Hospital who have stable COPD confirmed by pulmonary function testing.

描述

Inclusion Criteria:Patients with stable chronic obstructive pulmonary disease (COPD)

Diagnosed according to GOLD criteria (post-bronchodilator FEV1/FVC < 0.70)

-

Exclusion Criteria:

  1. Patient in exacerbation defined as change in the patient's baseline dyspnea, cough, and/or sputum beyond normal day-to-day variations within 14 days . (Ko, Fanny W., et al 2016)
  2. Connective tissue disease .
  3. Previously diagnosed Interstitial lung disease

  4. Contraindication to PFT According to ATS (Stanojevic S., et al 2021)

    • Recent Myocardial Infarction Within 1 week
    • Blood Pressure Instability Severe hypertension or systemic hypotension
    • Arrhythmias Significant, uncontrolled atrial or ventricular arrhythmias
    • Decompensated heart failure
    • Pulmonary Circulation Issues: Uncontrolled pulmonary hypertension, acute cor pulmonale, or clinically unstable pulmonary embolism
    • History of Syncope Loss of consciousness related to coughing or forced expiration
    • Cerebral Aneurysm
    • Recent Brain Surgery: Within 4 weeks
    • Concussion: Recent concussion with prolonged symptoms
    • Eye Surgery: Recent eye surgery within 1 week
    • Pneumothorax: Active or untreated pneumothorax Recent Thoracic Surgery: Within 4 weeks Recent Abdominal Surgery: Within 4 weeks Late-Term Pregnancy
  5. Contraindicatins of 6MWT according to ATS :

Absolute contraindications

  • Unstable Angina Experienced during the previous 1 month.
  • Recent Myocardial Infarction : Within the previous 1 month. Relative contraindications
  • Resting Tachycardia: Resting heart rate > 120{ bpm}.

  • Severe Uncontrolled Hypertension:

    • Systolic Blood Pressure > 180{ mmHg}
    • Diastolic Blood Pressure > 100{ mmHg}
  • Symptomatic/Severe Cardiac Conditions: High-degree atrioventricular (AV) block, hypertrophic cardiomyopathy, or symptomatic severe aortic stenosis.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Stable COPD Patients
Stable Chronic Obstructive Pulmonary Disease (COPD) patients undergoing quantitative volumetric High-Resolution Computed Tomography (HRCT) of the chest to evaluate parameters such as air trapping and lung volumes, combined with clinical assessment including mMRC dyspnea scale scoring and laboratory assessment including Cbc abg
诊断测试：Volumetric HRCT chest
Multidetector volumetric high-resolution computed tomography (≥64 slices, ≤1.0 mm slice thickness) performed during full inspiratory breath-hold and full expiratory breath-hold to quantitatively measure emphysema percentage (EM%), air trapping percentage (AT%), wall thickness (WT), wall area (WA) ,WA% and WT%
诊断测试：Spirometry and Body Plethysmography
Standardized pulmonary function testing performed according to ATS/ERS standards to measure post-bronchodilator forced expiratory volumes (FEV1, FVC) and static lung volumes (RV/TLC ratio).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Emphysema Percentage (EM%) Across GOLD Stages
大体时间：Baseline
Volumetric CT assessment quantifying the percentage of low-attenuation lung areas below -950 Hounsfield Units (%LAA-950) across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Baseline
Bronchial Wall Thickness (WT) Across GOLD Stages
大体时间：Baseline
Volumetric CT quantitative measurement of airway wall thickness evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4).Unit of measurements millimeter (mm).
Baseline
Percentage Wall Area (WA%) Across GOLD Stages
大体时间：Baseline
Volumetric CT quantitative measurement of bronchial wall area expressed as a percentage of total bronchial cross-sectional area across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Baseline
Air Trapping Percentage (AT%) Across GOLD Stages
大体时间：Baseline
Volumetric CT assessment evaluating the percentage of low-attenuation lung areas on paired expiratory CT scans (%LAA-856 or expiratory/inspiratory ratio) across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Baseline
Percentage Wall Thickness (WT%) Across GOLD Stages
大体时间：Baseline
Volumetric CT quantitative measurement of bronchial wall thickness expressed as a percentage of total bronchial outer diameter evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Percentage (%)
Baseline
Absolute Wall Area (WA) Across GOLD Stages
大体时间：Baseline
Volumetric CT quantitative measurement of absolute bronchial wall cross-sectional area evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4). Unit of Measure: Millimeter (mm)
Baseline

次要结果测量

结果测量
措施说明
大体时间
Correlation Coefficient Between CT Emphysema Percentage (EM%) and Spirometric FEV1/FVC Ratio
大体时间：Baseline (same day or within 1 week of HRCT scan)

Pearson's or Spearman's correlation coefficient evaluating the relationship between quantitative CT-derived emphysema percentage (%LAA-950) and post-bronchodilator FEV1/FVC ratio measured by spirometry.

Unit of Measure: Correlation coefficient (r)
Baseline (same day or within 1 week of HRCT scan)
Correlation Coefficient Between CT Air Trapping Percentage (AT%) and Plethysmographic RV/TLC Ratio
大体时间：Baseline (same day or within 1 week of HRCT scan)

Pearson's or Spearman's correlation coefficient evaluating the relationship between quantitative expiratory CT air trapping percentage (%LAA-856) and plethysmographic Residual Volume to Total Lung Capacity ratio (RV/TLC expressed as % predicted).

Unit of Measure: Correlation coefficient (r)
Baseline (same day or within 1 week of HRCT scan)

其他结果措施

结果测量
措施说明
大体时间
Correlation Coefficient Between CT Emphysema Percentage (EM%) and Arterial Oxygen Tension (pO2)
大体时间：Baseline

Pearson's or Spearman's correlation coefficient evaluating the relationship between quantitative CT-derived emphysema percentage (%LAA-950) and arterial blood gas oxygen tension (pO2 measured in mmHg).

Unit of Measure: Correlation coefficient (r)
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Mansoura University

调查人员

  • 首席研究员：Nesreen Shalabi、Professor of Chest Diseases

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年4月20日

初级完成 (实际的)

2026年5月20日

研究完成 (实际的)

2026年8月20日

研究注册日期

首次提交

2026年8月29日

首先提交符合 QC 标准的

2026年9月2日

首次发布 (实际的)

2026年9月9日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MS.25.02.3101

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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