Interstitial Lung DiseaseNCT04430491
To Evaluate the Use of Radiomics to Classify Between Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease
An observational study of Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Maastricht University at 1 site in Netherlands.
Trial summary
To investigate the ability of machine learning models based on radiomic features extracted from thin-section CT images to differentiate IPF patients from non-IPF interstitial lung diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Usual Interstitial Pneumonia
- What is being tested?
- radiomics
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2005to 1 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients referred to the hospital for lung disease. Two cohorts were included. One from Belgium, and a second one from the US.
Who may be able to join
- UIP with final diagnosis in biopsy
- ILDs with final diagnosis in biopsy
Who cannot join
- patients with no biopsy confirmation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center Validation of a Radiomics Based Model for the Diagnosis of Idiopathic Pulmonary Fibrosis
To investigate the ability of machine learning models based on radiomic features extracted from thin-section CT images to differentiate IPF patients from non-IPF interstitial lung diseases.
- Being tested
- radiomics
- Keywords
- Lung, CT, UIP, IPF, ILDs
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiomicsDiagnostic test
The high-throughput extraction of large amounts of quantitative image features from medical images
| Study group | Role | What they receive |
|---|---|---|
| Training dataset | No interventions Receives: Diagnostic Test: radiomics | |
| Validation dataset | No interventions Receives: Diagnostic Test: radiomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPF classifier
Model based on Radiomic that can differentiate IPF from ILDs.
Measured: Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start1 Jan 2005
- Primary completion1 Jan 2017
- Study completion1 Jul 2017
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430491
- Sponsor's protocol ID
- RESPIRE_2019
- Status last verified
- May 2020
- First submitted
- 1 May 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Validation of a Radiomics Based Model for the Diagnosis of Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT04430491
- Acronym / sponsor ID
- RESPIRE_2019
- Keywords
- Lung, CT, UIP, IPF, ILDs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 12 Jun 2020 (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.
To investigate the ability of machine learning models based on radiomic features extracted from thin-section CT images to differentiate IPF patients from non-IPF interstitial lung diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training dataset | – | Diagnostic Test: radiomicsNo interventions |
| Validation dataset | – | Diagnostic Test: radiomicsNo interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the hospital for lung disease. Two cohorts were included. One from Belgium, and a second one from the US.
Key inclusion criteria (2 listed)
- UIP with final diagnosis in biopsy
- ILDs with final diagnosis in biopsy
Key exclusion criteria (1 listed)
- patients with no biopsy confirmation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiomicsThe high-throughput extraction of large amounts of quantitative image features from medical images | Diagnostic test | Training dataset, Validation dataset |
Primary outcome
IPF classifier
Time frame: Up to 30 weeks
Model based on Radiomic that can differentiate IPF from ILDs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Maastricht University at 1 site in Netherlands.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 2020. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IPF classifier (time frame: Up to 30 weeks). 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 12 Jun 2020.