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

NCT05784207 | Completed DMC

• 1 other identifier: ISTRU
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease; Radiomics

Outcome Measures

Primary Outcomes (1)

• The performance of Radiomics algorithm compared to the ground truth

  Reporting the performance measure: accuracy

  May 2021

Secondary Outcomes (1)

• Comparing the performance of the radiomics algorithm to that of physicians

  June 2021

Other Outcomes (2)

• Comparing the performance of radiomics algorithm to that of individual doctor

  June 2021

• Comparing the reproducibility of diagnosis between the doctors

  June 2021

Study Arms (4)

IPF/UIP_CT based

patients with an ILD and a pathological UIP pattern and a final diagnosis of IPF

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)

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

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

Normal

Normal healthy patients

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

Interventions

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

ILD but not IPF and prove by biopsy not UIP; IPF/UIP_Biopsy based; IPF/UIP_CT based; Normal

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \- the availability of non-contrast-enhanced HRCT

You may not qualify if:

• the use of contrast enhancement
• images containing metal or motion artifacts
• Images reconstructed with a slice thickness larger than 1.5 mm

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: March 24, 2023
• Study Start: June 1, 2017
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

NL (1)