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Completed

NCT Number: NCT05784207

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

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).

Completed

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Radiomics Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiomics model to classify between IPF with UIP pattern and ILDs without UIP pattern

Other

The aim is to evaluate the performance of AI with the performance of doctors

Primary outcomes

  1. The performance of Radiomics algorithm compared to the ground truth

    Time frame: May 2021

    Reporting the performance measure: accuracy

Secondary outcomes

  1. Comparing the performance of the radiomics algorithm to that of physicians

    Time frame: June 2021

    Correctness of the diagnosis - the most probable thin-section pattern (dichotomous outcome: yes or no)

Other outcomes

  1. Comparing the performance of radiomics algorithm to that of individual doctor

    Time frame: June 2021

    Correctness of the diagnosis - the most probable thin-section pattern (dichotomous outcome: yes or no)

  2. Comparing the reproducibility of diagnosis between the doctors

    Time frame: June 2021

    Measuring the concordance in diagnosis in between the physicians, and for each physician separately, using the Concordance correlation coefficient.

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2023
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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