Inspiration Expiration Thoracic TDM Sequences of Patients With Diffuse Interstitial Lung Disease (DIP)MLQ-CTNCT06618924
Digital Modeling of Thoracic CT and Pulmonary Fibrosis
An observational study of Inspiration Expiration Thoracic TDM Sequences of Patients With Diffuse Interstitial Lung Disease (DIP), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inspiration Expiration Thoracic TDM Sequences of Patients With Diffuse Interstitial Lung Disease (DIP)
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2024to 1 Jul 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patients under 18 years of age.
- Patients under guardianship/curatorship.
- Patients under AME (State Medical Assistance).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Thoracic TDM, DIP
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative and quantitative parameters obtained by in silico modeling of interstitial pattern, intra-pulmonary vascular remodeling and airway remodeling.
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.
Measured: At 12 months after initial CT scan
Specific mechanical parameters obtained by dynamic poromechanical modeling obtained by dynamic poromechanical modeling.
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.
Measured: At 12 months after initial CT scan
Secondary outcomes (3)
indexes of interstitial pattern score
- 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.
Measured: At 12 months after initial CT scan
intra-pulmonary vascular remodeling and airway remodeling score
- 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.
Measured: At 12 months after initial CT scan
poromechanical stiffness score
- 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.
Measured: At 12 months after initial CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jul 2024
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inspiration Expiration Thoracic TDM Sequences of Patients With Diffuse Interstitial Lung Disease (DIP)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves Brillet, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618924
- Sponsor's protocol ID
- APHP240681
- Acronym
- MLQ-CT
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Multi-compartment Study by Thoracic CT Scanning in Progressive Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06618924
- Acronym / sponsor ID
- MLQ-CT / APHP240681
- Keywords
- Thoracic TDM, DIP
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Patients under 18 years of age.
- Patients under guardianship/curatorship.
- Patients under AME (State Medical Assistance).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
indexes of interstitial pattern score
Time frame: At 12 months after initial CT scan
intra-pulmonary vascular remodeling and airway remodeling score
Time frame: At 12 months after initial CT scan
poromechanical stiffness score
Time frame: At 12 months after initial CT scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Yves Brillet, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inspiration Expiration Thoracic TDM Sequences of Patients With Diffuse Interstitial Lung Disease (DIP), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.