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NCT Number: NCT05947422

CT Quantitative Assessment of Interstitial Lung Disease

Interstitial lung disease (ILD) refers to a broad category of heterogeneous lung diseases with different etiologies and features characterized by inflammation and fibrosis of the lung parenchyma and manifested as exertional dyspnea, interstitial patterns on high resolution computed tomography (HRCT), and abnormal pulmonary function tests (PFTs) The aim of this study is to investigate is there any correlation between changes seen in the lung parenchyma by HRCT and the pulmonary functions of the patients.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location status: Recruiting

Location contact

Ramy M Ahmed, MD

CONTACT

01153070865

About this study

This study will utilize a cross-sectional prospective study design in a single institution to investigate the correlation between CT chest findings including lung densitometry and pulmonary function test results in patients with ILD.

The study population will consist of consecutive patients diagnosed with ILD recruited from the pulmonary clinic or inpatient service.

High resolution CT chest and pulmonary function tests are routine diagnostic tests used for diagnosis of interstitial lung disease .

both tests are non invasive for the patient and will be acquired for all patients and then their results will be correlated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of ILD (based on clinical, radiological, and pulmonary function criteria +/- histopathological criteria).
  • Availability of CT chest DICOM images and pulmonary function test results (within a 2-weeks period from each other).

Exclusion criteria

  • Pregnancy
  • Pulmonary edema.
  • Primary pulmonary hypertension;
  • Chronic obstructive pulmonary disease
  • Congestive heart failure

Treatment and study plan

High resolution CT Chest

Diagnostic Test

CT chest in our institution will be done with standard high resolution protocol . No I.V contrast will be given. Scans will be obtained during full inspiration in supine position from the thoracic inlet to the level of the diaphragm.

Patients with CT chest performed outside our institution will be reviewed in DICOM format and assessed for its compatibility to be integrated into the computer-based analysis software.

Spirometry

Diagnostic Test

Spirometry will be performed using standard techniques according to ATS-ERS criteria 2019 . Spirometry device (Zan 300, NSPIRE HEALTH GMBH Co.) will be used. Percentage predicted values (%pred) will be calculated based on reference values for healthy adults. All patients will be required to undergo spirometry in a reproducible way, and the best values will be reported. Spirometry should meet international acceptability and repeatability standards

Primary outcomes

  1. CT visual Warrick score (measured by points)

    Time frame: baseline

    Warrick score is calculated as follow : A point value will be given to each abnormality i.e ground-glass appearance (areas of hazy opacity in the lung that do not obscure the underlying bronchial structures) = 1, irregular pleural margins = 2, septal/subpleural lines = 3, honeycombing (usually 3-10 mm in diameter and have thick walls) = 4, and subpleural cysts = 5. In each patient, the "severity of disease" score will be obtained by adding single point values (maximal severity score 15).

    An "extent of disease" score is obtained by counting the number of bronchopulmonary segments involved for each abnormality as follows ; one to three segments scored as 1, four to nine segments scored as 2, and more than nine segments scored as 3 (maximal extent score 15).

    The severity and extent of disease will be then calculated as the total Warrick score (range from 0 to 30)

  2. Total lung volume, Volume of lung occupied by low attenuation areas, Volume of lung occupied by high attenuation areas, Volume of normal lung areas and volume of consolidation areas

    Time frame: baseline

    Total lung volume , volume of the lung occupied by low attenuation areas (attenuation values from -1024 to -950 HU; representing emphysema), volume of normally attenuated lung (from -949 to -700 HU; corresponds to healthy lung tissue) and volume of the lung occupied by high attenuation areas (between - 699 and - 250 HU) ; it represents the lung parts which are more dense than healthy lung); volume of lung with density from -249 to +40 HU, this group corresponds to areas with further increase in density, including the semi-consolidation and consolidation.

  3. Percentage of the lung occupied by low attenuation areas, percentage of normal lung, percentage of the lung occupied by high attenuation areas and percentage of consolidation areas.

    Time frame: baseline

    Percentage of the lung occupied by low attenuation areas (attenuation values from -1024 to -950 HU), percentage of normal lung (from -949 to -700 HU), percentage of the lung occupied by high attenuation areas (between - 699 and - 250 HU) and percentage of consolidation areas (from -249 to +40 HU) in each lung and in each lobe.

  4. Mean lung density of each lung, both lungs and every lobe in Hounsfield unit (HU)

    Time frame: baseline

    Mean lung density of each lung , both lungs and each lung lobe (e.g., upper, middle, and lower lobes) will be measured in Hounsfield unit (HU).

  5. Forced vital capacity (FVC)

    Time frame: baseline

    Forced vital capacity (FVC) will be measures using spirometer and expressed as percentage.

  6. Forced expiratory volume in 1 second (FEV1)

    Time frame: baseline

    Forced expiratory volume in 1 second (FEV1)

  7. FEV1/FVC ratio

    Time frame: baseline

    FEV1/FVC ratio will be measures

  8. O2 saturation

    Time frame: baseline

    O2 saturation is measured in percentage (SpO2) using pulse oximeter

Study contacts

Contact information is provided by the study sponsor or research team.

Ramy M Ahmed, MD

CONTACT

[email protected]

+201153070865

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

CT Quantitative Assessment of Interstitial Lung Disease Using Visual Score and Lung Densitometry Methods and Its Correlation With Pulmonary Function Tests

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2023
Registry last updated
May 1, 2025

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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