NCT04430491

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Last Updated

June 12, 2020

Status Verified

May 1, 2020

Enrollment Period

12 years

First QC Date

May 1, 2020

Last Update Submit

June 11, 2020

Conditions

Interstitial Lung DiseaseIdiopathic Pulmonary FibrosisUsual Interstitial Pneumonia

Keywords

LungCTUIPIPFILDs

Outcome Measures

Primary Outcomes (1)

  • IPF classifier

    Model based on Radiomic that can differentiate IPF from ILDs.

    Up to 30 weeks

Study Arms (2)

Training dataset

No interventions

Diagnostic Test: radiomics

Validation dataset

No interventions

Diagnostic Test: radiomics

Interventions

radiomicsDIAGNOSTIC_TEST

The high-throughput extraction of large amounts of quantitative image features from medical images

Training datasetValidation dataset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • UIP with final diagnosis in biopsy
  • ILDs with final diagnosis in biopsy

You may not qualify if:

  • patients with no biopsy confirmation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Lung Diseases, InterstitialIdiopathic Pulmonary Fibrosis

Interventions

Radiomics

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPulmonary Fibrosis

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

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

Study Record Dates

First Submitted

May 1, 2020

First Posted

June 12, 2020

Study Start

January 1, 2005

Primary Completion

January 1, 2017

Study Completion

July 1, 2017

Last Updated

June 12, 2020

Record last verified: 2020-05

Locations

NL(1)