Evaluation of the Reproducibility of the Automated Measurement of the Extent of ILD on Chest CT (REPRO-PID)

December 29, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Evaluation of the Reproducibility of the Automated Measurement of the Extent of Interstitial Lung Disease on Chest CT

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • IDF
      • Paris, IDF, France, 75010
      • Paris, IDF, France, 75010
      • Paris, IDF, France, 75014
      • Paris, IDF, France, 75014
      • Paris, IDF, France, 75014
        • Recruiting
        • APHP - Cochin Hospital - Radiology
        • Contact:
        • Sub-Investigator:
          • Marie-Pierre REVEL, MD, PhD
      • Paris, IDF, France, 75018
        • Recruiting
        • APHP - Bichat Hospital - Pneumology
        • Contact:
        • Sub-Investigator:
          • Pierre LE GUEN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with interstitial lung disease
Diagnostic test: Chest CT
Repeated chest CT for automated ILD quantification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automated Interstitial Lung Disease (ILD) quantification
Time Frame: Day of inclusion
Reproducibility of ILD quantification on chest CT (as a percentage of lung volume) between two successive scan acquisitions.
Day of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Automated Interstitial Lung Disease (ILD) quantification
Time Frame: Day of inclusion
Reproducibility of disease extent measured with different software on the same acquisition
Day of inclusion
Lung volume
Time Frame: Day of inclusion
Reproducibility of total lung volume measured on the scanner between two successive acquisitions
Day of inclusion
Automated Interstitial Lung Disease (ILD) quantification
Time Frame: Day of inclusion
Reproducibility of disease extension between the two scan acquisitions depending on the disease (idiopathic pulmonary fibrosis or PID secondary to connective tissue disease).
Day of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Principal Investigator: Guillaume CHASSAGNON, MD, PhD, Cochin Hospital - AP-HP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP240783
  • 2024-A01384-43 (Other Identifier: France : Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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