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

• Sponsor: Maastricht University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05784207
• Collaborator: (none)
• Enrollment: 145
• Location: 1
• Actual Duration (Months): 55
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease; Radiomics	Other: Radiomics model to classify between IPF with UIP pattern and ILDs without UIP pattern

Study Design

• Study Type: Observational
• Actual Enrollment: 145 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: An In Silico Trial to Evaluate Prospectively the Performance of a Radiomics Algorithm for UIP Compared to Medical Doctors
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Dec 30, 2021
• Actual Study Completion Date: Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; The aim is to evaluate the performance of AI with the performance of doctors
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; The aim is to evaluate the performance of AI with the performance of doctors
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; The aim is to evaluate the performance of AI with the performance of doctors
Normal Normal healthy patients	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

Outcome Measures

Primary Outcome Measures

1. The performance of Radiomics algorithm compared to the ground truth [May 2021]

   Reporting the performance measure: accuracy

Secondary Outcome Measures

1. Comparing the performance of the radiomics algorithm to that of physicians [June 2021]

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

Other Outcome Measures

1. Comparing the performance of radiomics algorithm to that of individual doctor [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 [June 2021]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University	Maastricht	Limburg	Netherlands	6229ER

Sponsors and Collaborators

• Maastricht University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University
• ClinicalTrials.gov Identifier: NCT05784207
• Other Study ID Numbers: ISTRU
• First Posted: Mar 24, 2023
• Last Update Posted: Mar 24, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial

Study Results

No Results Posted as of Mar 24, 2023