Clinical trial NCT06743022: Evaluation of the Reproducibility of the Automated Measurement of the Extent of ILD on Chest CT
Official title: Evaluation of the Reproducibility of the Automated Measurement of the Extent of Interstitial Lung Disease on Chest CT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: Lung Diseases
Interstitial Lung Disease
Multidetector Computed Tomography
Deep Learning
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In interstitial lung disease (ILD), the extent of ILD on chest computed tomography (CT) is recognized as an important prognostic factor. Automated tools are now available to quantify ILD, but there is a lack of data on the reproducibility of this measurement and therefore its accuracy.

Therefore, the purpose of this study is to evaluate the variability of automated ILD quantification on chest CT. Reproducibility will be assessed by repeating chest CT scans and using different tools to measure the extent of disease.

Detailed description: In interstitial lung disease (ILD), the extent of ILD on chest computed tomography (CT) is recognized as an important prognostic factor. In recent years, several tools based on texture analysis or deep learning methods have been developed to provide rapid and accurate automated quantification of ILD extent.

An advantage of automated scoring methods is that they theoretically offer perfect repeatability of measurement. However, this is only true if the measurement is repeated on the same images. Several parameters can alter the appearance of the lungs on scanner images, such as the degree of inspiration or the reconstruction kernel used to reconstruct the images. There is a lack of data on the reproducibility of the whole process of automated ILD quantification and therefore its accuracy.

Therefore, the purpose of this study is to evaluate the variability of automated ILD quantification on chest CT.

Reproducibility will be assessed by repeating chest CT scans and using different tools to measure the extent of disease in patients with ILD from 2 institutions. Chest CT will be repeated the same day. This will allow assessment of the variability of automated measurement of ILD extent between 2 CT scans performed on the same day and when using different software. It will also allow to assess the variability of lung volume between the 2 CT scans and the effect of disease (idiopathic pulmonary fibrosis or connective tissue disease-related ILD) on the reproducibility of ILD quantification.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Known interstitial lung disease as part of idiopathic pulmonary fibrosis or connective tissue disease
* Followed in one of the participating hospitals
* Requiring a chest CT as part of a scheduled assessment
* Affiliated to a French national social security
* Informed consent

Exclusion Criteria:

* Acute exacerbation of ILD
* Pregnancy
* Inability to hold an apnea for 10 seconds
* Patients in the exclusion period after a previous research
* Need for additional procubitus or expiratory images

Primary outcomes:
measure: Automated Interstitial Lung Disease (ILD) quantification
timeFrame: Day of inclusion
Secondary outcomes:
measure: Automated Interstitial Lung Disease (ILD) quantification
timeFrame: Day of inclusion
measure: Lung volume
timeFrame: Day of inclusion
measure: Automated Interstitial Lung Disease (ILD) quantification
timeFrame: Day of inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP - Bichat hospital - Radiology
state: IDF
city: Paris
country: France
facility: APHP - Bichat hospital - Rheumatology
state: IDF
city: Paris
country: France
facility: APHP - Cochin Hospital - Internal medicine
state: IDF
city: Paris
country: France
facility: APHP - Cochin Hospital - Pneumology
state: IDF
city: Paris
country: France
facility: APHP - Cochin Hospital - Radiology
state: IDF
city: Paris
country: France
facility: APHP - Bichat Hospital - Pneumology
state: IDF
Study officials:
affiliation: Cochin Hospital - AP-HP
name: Guillaume CHASSAGNON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: