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NCT05784207 Clinical Trial

An In Silico Trial to Evaluate Prospectively the Performance of a Radiomics Algorithm for UIP Compared to Medical Doctors

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
An In Silico Trial to Evaluate Prospectively the Performance of a Radiomics Algorithm for UIP Compared to Medical Doctors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05784207
Other study ID # ISTRU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date December 30, 2021

Study information
Verified date March 2023
Source Maastricht University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).

Recruitment information / eligibility
Status Completed
Enrollment 145
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - the availability of non-contrast-enhanced HRCT Exclusion Criteria: - the use of contrast enhancement - images containing metal or motion artifacts - Images reconstructed with a slice thickness larger than 1.5 mm

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Radiomics model to classify between IPF with UIP pattern and ILDs without UIP pattern
The aim is to evaluate the performance of AI with the performance of doctors

Locations
Country Name City State
Netherlands Maastricht University Maastricht Limburg

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Other Comparing the performance of radiomics algorithm to that of individual doctor Correctness of the diagnosis - the most probable thin-section pattern (dichotomous outcome: yes or no) June 2021
Other Comparing the reproducibility of diagnosis between the doctors Measuring the concordance in diagnosis in between the physicians, and for each physician separately, using the Concordance correlation coefficient. June 2021
Primary The performance of Radiomics algorithm compared to the ground truth Reporting the performance measure: accuracy May 2021
Secondary 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) June 2021
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