CT Quantitative Assessment of Interstitial Lung Disease

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 90 years
• All sexes
• No healthy volunteers
• Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Interstitial Lung Disease

Being tested

High resolution CT Chest, Spirometry

Medical subject headings

Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• High resolution CT ChestDiagnostic test

  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.

• SpirometryDiagnostic test

  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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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)

   Measured: baseline

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

   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.

   Measured: baseline

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.

   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.

   Measured: baseline

4. 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).

   Measured: baseline

5. Forced vital capacity (FVC)

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

   Measured: baseline

6. Forced expiratory volume in 1 second (FEV1)

   Forced expiratory volume in 1 second (FEV1)

   Measured: baseline

7. FEV1/FVC ratio

   FEV1/FVC ratio will be measures

   Measured: baseline

8. O2 saturation

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

   Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted17 Jul 2023
2. Study start1 Dec 2023
3. Primary completion1 Dec 2025 (estimated)
4. Study completion30 Dec 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
• More trials run by Assiut UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.