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Completed

NCT Number: NCT07809399

Volumetric HRCT in Stable COPD Patients.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mansoura University Hospital (Chest Disease Department)

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with stable chronic obstructive pulmonary disease (COPD)

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

-

Exclusion criteria

  • 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)
  • Connective tissue disease .
  • Previously diagnosed Interstitial lung disease
  • 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
  • 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.

Treatment and study plan

Volumetric HRCT chest

Diagnostic Test

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%

Spirometry and Body Plethysmography

Diagnostic Test

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).

Primary outcomes

  1. Emphysema Percentage (EM%) Across GOLD Stages

    Time frame: 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 (%)

  2. Bronchial Wall Thickness (WT) Across GOLD Stages

    Time frame: 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).

  3. Percentage Wall Area (WA%) Across GOLD Stages

    Time frame: 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 (%)

  4. Air Trapping Percentage (AT%) Across GOLD Stages

    Time frame: 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 (%)

  5. Percentage Wall Thickness (WT%) Across GOLD Stages

    Time frame: 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 (%)

  6. Absolute Wall Area (WA) Across GOLD Stages

    Time frame: 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)

Secondary outcomes

  1. Correlation Coefficient Between CT Emphysema Percentage (EM%) and Spirometric FEV1/FVC Ratio

    Time frame: 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)

  2. Correlation Coefficient Between CT Air Trapping Percentage (AT%) and Plethysmographic RV/TLC Ratio

    Time frame: 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)

Other outcomes

  1. Correlation Coefficient Between CT Emphysema Percentage (EM%) and Arterial Oxygen Tension (pO2)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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