Idiopathic Pulmonary FibrosisNCT05784207
An In Silico Trial to Evaluate Prospectively the Performance of a Radiomics Algorithm for UIP Compared to Medical Doctors
An observational study of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, run by Maastricht University at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare AI performance to doctor's performance in the evaluation of IPF/UIP and ILDs without UIP(proven by biopsy). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Radiomics
- What is being tested?
- Radiomics model to classify between IPF with UIP pattern and ILDs without UIP pattern
- How many people
- 145 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2017to 30 Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who had HRCT and shown IPF/UIP in CT images, or patients who is suspected to have IPF based on MMD and proved by lung biopsy.
Who may be able to join
- the availability of non-contrast-enhanced HRCT
Who cannot join
- the use of contrast enhancement
- images containing metal or motion artifacts
- Images reconstructed with a slice thickness larger than 1.5 mm
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare AI performance to doctor's performance in the evaluation of IPF/UIP and ILDs without UIP(proven by biopsy).
- Being tested
- Radiomics model to classify between IPF with UIP pattern and ILDs without UIP pattern
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomics model to classify between IPF with UIP pattern and ILDs without UIP patternOther
The aim is to evaluate the performance of AI with the performance of doctors
| Study group | Role | What they receive |
|---|---|---|
| IPF/UIP_CT based | patients with an ILD and a pathological UIP pattern and a final diagnosis of IPF Receives: Other: Radiomics model to classify between IPF with UIP pattern and ILDs without UIP pattern | |
| IPF/UIP_Biopsy based | patients with a final diagnosis of IPF but a less typical HRCT pattern( lung biopsy required for the diagnosis) Receives: Other: Radiomics model to classify between IPF with UIP pattern and ILDs without UIP pattern | |
| ILD but not IPF and prove by biopsy not UIP | patients with an ILD and a pathological non-UIP pattern Receives: Other: Radiomics model to classify between IPF with UIP pattern and ILDs without UIP pattern | |
| Normal | Normal healthy patients Receives: Other: Radiomics model to classify between IPF with UIP pattern and ILDs without UIP pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of Radiomics algorithm compared to the ground truth
Reporting the performance measure: accuracy
Measured: May 2021
Secondary outcomes (1)
Comparing the performance of the radiomics algorithm to that of physicians
Correctness of the diagnosis - the most probable thin-section pattern (dichotomous outcome: yes or no)
Measured: June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jun 2017
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784207
- Sponsor's protocol ID
- ISTRU
- Status last verified
- Mar 2023
- First submitted
- 19 May 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In Silico Trial to Evaluate Prospectively the Performance of a Radiomics Algorithm for UIP Compared to Medical Doctors
- ClinicalTrials.gov ID
- NCT05784207
- Acronym / sponsor ID
- ISTRU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Mar 2023 (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.
The purpose of this study is to compare AI performance to doctor's performance in the evaluation of IPF/UIP and ILDs without UIP(proven by biopsy).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IPF/UIP_CT based | – | Other: Radiomics model to classify between IPF with UIP pattern and ILDs without UIP patternpatients with an ILD and a pathological UIP pattern and a final diagnosis of IPF |
| IPF/UIP_Biopsy based | – | Other: Radiomics model to classify between IPF with UIP pattern and ILDs without UIP patternpatients with a final diagnosis of IPF but a less typical HRCT pattern( lung biopsy required for the diagnosis) |
| ILD but not IPF and prove by biopsy not UIP | – | Other: Radiomics model to classify between IPF with UIP pattern and ILDs without UIP patternpatients with an ILD and a pathological non-UIP pattern |
| Normal | – | Other: Radiomics model to classify between IPF with UIP pattern and ILDs without UIP patternNormal healthy patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had HRCT and shown IPF/UIP in CT images, or patients who is suspected to have IPF based on MMD and proved by lung biopsy.
Key inclusion criteria (1 listed)
- the availability of non-contrast-enhanced HRCT
Key exclusion criteria (3 listed)
- the use of contrast enhancement
- images containing metal or motion artifacts
- Images reconstructed with a slice thickness larger than 1.5 mm
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 |
|---|---|---|
| Radiomics model to classify between IPF with UIP pattern and ILDs without UIP patternThe aim is to evaluate the performance of AI with the performance of doctors | Other | ILD but not IPF and prove by biopsy not UIP, IPF/UIP_Biopsy based, IPF/UIP_CT based, Normal |
Primary outcome
The performance of Radiomics algorithm compared to the ground truth
Time frame: May 2021
Reporting the performance measure: accuracy
1 secondary outcome
Comparing the performance of the radiomics algorithm to that of physicians
Time frame: June 2021
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 24 Mar 2023.
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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 Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, 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 1 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: finished, as of the sponsor's last update on 24 Mar 2023. 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?
The performance of Radiomics algorithm compared to the ground truth (time frame: May 2021). 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 24 Mar 2023.