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Volumetric HRCT in Stable COPD Patients.

2 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

75

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Egitto
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egitto, 35516
        • Mansoura University Hospital (Chest Disease Department)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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
Test diagnostico: 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%
Test diagnostico: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Emphysema Percentage (EM%) Across GOLD Stages
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation Coefficient Between CT Emphysema Percentage (EM%) and Spirometric FEV1/FVC Ratio
Lasso di tempo: 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
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Correlation Coefficient Between CT Emphysema Percentage (EM%) and Arterial Oxygen Tension (pO2)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mansoura University

Investigatori

  • Investigatore principale: Nesreen Shalabi, Professor of Chest Diseases

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 aprile 2025

Completamento primario (Effettivo)

20 maggio 2026

Completamento dello studio (Effettivo)

20 agosto 2026

Date di iscrizione allo studio

Primo inviato

29 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 settembre 2026

Primo Inserito (Effettivo)

9 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MS.25.02.3101

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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