To Evaluate the Use of Radiomics to Classify Between Idio... | NCT04430491

Studies
To Evaluate the Use of Radiomics to Classify Between Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease

NCT04430491

Sponsor

Maastricht University

Status

Completed

Last Update Posted

Jun 12, 2020Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Usual Interstitial Pneumonia

Interventions

radiomics

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2005Actual

Primary Completion Date

Jan 1, 2017Actual

Completion Date

Jul 1, 2017Actual

First Submitted Date

May 1, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2020

Last Update Posted Date

Jun 12, 2020Actual

Name	Class
Université Libre de Bruxelles	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training dataset		No interventions	Diagnostic Test: radiomics
Validation dataset		No interventions	Diagnostic Test: radiomics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiomics	Diagnostic Test	The high-throughput extraction of large amounts of quantitative image features from medical images	Training dataset Validation dataset

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IPF classifier	Model based on Radiomic that can differentiate IPF from ILDs.	Up to 30 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patients with no biopsy confirmation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients referred to the hospital for lung disease. Two cohorts were included. One from Belgium, and a second one from the US.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		Maastricht	Limburg	6229ER	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial
D054990	Idiopathic Pulmonary Fibrosis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D011658	Pulmonary Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000097188	Radiomics

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided