Digital Modeling of Thoracic CT and Pulmonary Fibrosis (MLQ-CT)

September 27, 2024 updated by: Assistance Publique - Hôpitaux de Paris

Quantitative Multi-compartment Study by Thoracic CT Scanning in Progressive Pulmonary Fibrosis

Currently, to our knowledge, there is little data on the combination of tools based on a similar concept to understand and evaluate ILDs. It is expected that this portfolio of multi-tool software implemented in radiology departments, applied to routine thoracic TDM, will provide additional qualitative and quantitative information in real time that will be of great help for diagnosis, prognosis prediction, and treatment decision-making in ILDs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Thoracic CT scanning has revolutionized the definition of interstitial lung diseases (ILDs), some of which inexorably progress to pulmonary fibrosis (e.g., progressive pulmonary fibrosis or PPF), leading to early death or lung transplantation. Over the past decade, various treatments have shown effectiveness in slowing this fibrotic progression, but it is still not possible to define which patients might personally benefit from these treatments and when to prescribe them. Two major questions remain:

Why do some patients develop fibrosis despite seemingly appropriate treatment? What are the mechanisms driving this fibrotic progression? Hence, there is a great need to define biomarkers to answer these questions, particularly in the early phase. For more than 5 years, within a consortium including Avicenne Hospital APHP 93000 Bobigny, INSERM Unit 1272 Sorbonne Paris North University, and two partner laboratories (Mines Telecom and Ecole Polytechnique-INRIA, both belonging to the Institut Polytechnique), we have been developing the applications of artificial intelligence (AI) to lung imaging, extracting static and dynamic data from thoracic CT scans to aid in the diagnosis and follow-up of patients without additional examinations beyond standard care. Our project's objective is to identify patients at risk of progressive and irreversible fibrosis and those who could respond to antifibrotic treatments, by developing the identification of qualitative and quantitative biomarkers from the numerical modeling of routine thoracic CT scans.

Our program, which has just been funded in 2023 by the National Research Agency (ANR 2023 MLQ-CT), aims to:

Develop a portfolio of software tools, whose use should be facilitated in the hospital sector based on research prototypes already built and tested in our consortium for several years.

Apply them to a set of interstitial lung diseases (ILDs) known to be at risk of fibrotic progression.

Transfer these tools to the radiology department of Avicenne Hospital APHP. Conduct real-time experimentation between two pulmonology departments, one at Avicenne Hospital APHP and the other at Caen University Hospital, and the radiology department of Avicenne Hospital APHP, to validate the feasibility of using such biomarkers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

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

Study Locations

  • France
      • Bobigny, France
        • Hôpital Avicenne APHP

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Retrospective data from patients monitored for ILDs who underwent two thoracic TDM scans in inspiration and expiration (IE-TDM) at least one year apart, whether meeting the criteria for progressive fibrosis or not.

Description

Inclusion criteria:

  • Informed patients who have consented to participate in the research.
  • Retrospective data from patients followed for ILDs who underwent two thoracic TDM scans in inspiration and expiration (IE-TDM) at least one year apart, meeting or not meeting the criteria for progressive fibrosis [presence of two of the following criteria within one year of follow-up: 1/clinical worsening, 2/radiological evidence of disease progression between the two IE-TDM scans, 3/decline in FVC ≥5% or absolute decrease in DLCO (corrected for Hb) > 10%].
  • 300 records, based on retrospective data, will constitute the initial AVICENNE database (500 records will be selected at Avicenne Hospital APHP so that 300 meet the quality criteria for inspiration/expiration thoracic TDM scans)

Exclusion criteria:

  • Patients under 18 years of age.
  • Patients under guardianship/curatorship.
  • Patients under AME (State Medical Assistance).

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Qualitative and quantitative parameters obtained by in silico modeling of interstitial pattern, intra-pulmonary vascular remodeling and airway remodeling.
Time Frame: At 12 months after initial CT scan
Identify patients at risk of progressive and irreversible fibrosis and those who could respond to antifibrotic treatments, by developing the identification of qualitative and quantitative biomarkers from the numerical modeling of routine thoracic CT scans.
At 12 months after initial CT scan
Specific mechanical parameters obtained by dynamic poromechanical modeling obtained by dynamic poromechanical modeling.
Time Frame: At 12 months after initial CT scan
Identify patients at risk of progressive and irreversible fibrosis and those who could respond to antifibrotic treatments, by developing the identification of qualitative and quantitative biomarkers from the numerical modeling of routine thoracic CT scans.
At 12 months after initial CT scan

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
indexes of interstitial pattern score
Time Frame: At 12 months after initial CT scan
  • Bring the various software products in this portfolio up to Technology Readiness Level (TRL) 6 in order to create a prototype based on this portfolio; that can be implanted in a hospital environment
  • test the feasibility of inter-connecting the radiology and pneumology departments of two university hospitals to this prototype, implanted in the radiology department of the Hôpital Avicenne APHP.
At 12 months after initial CT scan
intra-pulmonary vascular remodeling and airway remodeling score
Time Frame: At 12 months after initial CT scan
  • Bring the various software products in this portfolio up to Technology Readiness Level (TRL) 6 in order to create a prototype based on this portfolio; that can be implanted in a hospital environment
  • test the feasibility of inter-connecting the radiology and pneumology departments of two university hospitals to this prototype, implanted in the radiology department of the Hôpital Avicenne APHP.
At 12 months after initial CT scan
poromechanical stiffness score
Time Frame: At 12 months after initial CT scan
  • Bring the various software products in this portfolio up to Technology Readiness Level (TRL) 6 in order to create a prototype based on this portfolio; that can be implanted in a hospital environment
  • test the feasibility of inter-connecting the radiology and pneumology departments of two university hospitals to this prototype, implanted in the radiology department of the Hôpital Avicenne APHP.
At 12 months after initial CT scan

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre-Yves Brillet, Pr, Assistance Publique - Hôpitaux de Paris

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP240681

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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