CT Quantitative Assessment of Interstitial Lung Disease

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05947422
• Other study ID #: ILD-CT
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Ramy M Ahmed, MD
• Phone: +201153070865
• Email: ramycolor[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT visual Warrick score (measured by points)	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)	baseline
Primary	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	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.	baseline
Primary	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.	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.	baseline
Primary	Mean lung density of each lung, both lungs and every lobe in Hounsfield unit (HU)	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).	baseline
Primary	Forced vital capacity (FVC)	Forced vital capacity (FVC) will be measures using spirometer and expressed as percentage.	baseline
Primary	Forced expiratory volume in 1 second (FEV1)	Forced expiratory volume in 1 second (FEV1)	baseline
Primary	FEV1/FVC ratio	FEV1/FVC ratio will be measures	baseline
Primary	O2 saturation	O2 saturation is measured in percentage (SpO2) using pulse oximeter	baseline