CT Quantitative Assessment of Interstitial Lung Disease

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Diagnostic test: High resolution CT Chest; Diagnostic test: Spirometry

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Ramy M Ahmed, MD; Phone Number: +201153070865; Email: ramycolor@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Forced vital capacity (FVC)	Forced vital capacity (FVC) will be measures using spirometer and expressed as percentage.	baseline
Forced expiratory volume in 1 second (FEV1)	Forced expiratory volume in 1 second (FEV1)	baseline
FEV1/FVC ratio	FEV1/FVC ratio will be measures	baseline
O2 saturation	O2 saturation is measured in percentage (SpO2) using pulse oximeter	baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ramy M Ahmed, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: ILD-CT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No