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Recruiting NCT05947422

CT Quantitative Assessment of Interstitial Lung Disease

Observational Interstitial Lung Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High resolution CT Chest, Spirometry.
Who it may be relevant to
Registry conditions: Interstitial Lung Disease. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test High resolution CT Chest
    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.
  • Diagnostic test Spirometry
    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 outcome measures

  • CT visual Warrick score (measured by points) [Time frame: baseline]
  • 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]
  • 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]
  • Mean lung density of each lung, both lungs and every lobe in Hounsfield unit (HU) [Time frame: baseline]
  • Forced vital capacity (FVC) [Time frame: baseline]
  • Forced expiratory volume in 1 second (FEV1) [Time frame: baseline]
  • FEV1/FVC ratio [Time frame: baseline]
  • O2 saturation [Time frame: baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Egypt · 1 center
  • Assiut University Hospital — Asyut

Identifiers

NCT: NCT05947422 · ILD-CT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗