Clinical trial NCT05947422: CT Quantitative Assessment of Interstitial Lung Disease
Official title: CT Quantitative Assessment of Interstitial Lung Disease Using Visual Score and Lung Densitometry Methods and Its Correlation With Pulmonary Function Tests
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of consecutive patients diagnosed with ILD recruited from the pulmonary clinic or inpatient service. The diagnosis of ILD will be based on American Thoracic Society/European Respiratory Society (ATS/ERS) classification system for ILD.

Brief summary: 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.

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

Primary outcomes:
measure: CT visual Warrick score (measured by points)
timeFrame: baseline
measure: 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
timeFrame: baseline
measure: 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.
timeFrame: baseline
measure: Mean lung density of each lung, both lungs and every lobe in Hounsfield unit (HU)
timeFrame: baseline
measure: Forced vital capacity (FVC)
timeFrame: baseline
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: baseline
measure: FEV1/FVC ratio
timeFrame: baseline
measure: O2 saturation
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Ramy M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: