CT Quantitative Assessment of Interstitial Lung Disease

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05947422
Collaborator
(none)
70
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
70 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
CT Quantitative Assessment of Interstitial Lung Disease Using Visual Score and Lung Densitometry Methods and Its Correlation With Pulmonary Function Tests
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Outcome Measures

Primary Outcome Measures

  1. CT visual Warrick score (measured by points) [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 [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. [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) [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) [baseline]

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

  6. Forced expiratory volume in 1 second (FEV1) [baseline]

    Forced expiratory volume in 1 second (FEV1)

  7. FEV1/FVC ratio [baseline]

    FEV1/FVC ratio will be measures

  8. O2 saturation [baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramy Mohammed Ahmed, lecturer and consultant of diagnostic an dintervention radiology, Assiut University
ClinicalTrials.gov Identifier:
NCT05947422
Other Study ID Numbers:
  • ILD-CT
First Posted:
Jul 17, 2023
Last Update Posted:
Jul 17, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2023