- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04430491
To Evaluate the Use of Radiomics to Classify Between Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease
June 11, 2020 updated by: Maastricht University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- Maastricht University
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients referred to the hospital for lung disease.
Two cohorts were included.
One from Belgium, and a second one from the US.
Description
Inclusion Criteria:
- UIP with final diagnosis in biopsy
- ILDs with final diagnosis in biopsy
Exclusion Criteria:
- patients with no biopsy confirmation
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Training dataset
No interventions
|
The high-throughput extraction of large amounts of quantitative image features from medical images
|
Validation dataset
No interventions
|
The high-throughput extraction of large amounts of quantitative image features from medical images
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IPF classifier
Time Frame: Up to 30 weeks
|
Model based on Radiomic that can differentiate IPF from ILDs.
|
Up to 30 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
January 1, 2005
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
May 1, 2020
First Submitted That Met QC Criteria
June 11, 2020
First Posted (Actual)
June 12, 2020
Study Record Updates
Last Update Posted (Actual)
June 12, 2020
Last Update Submitted That Met QC Criteria
June 11, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RESPIRE_2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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