Imaging Signature of Progressive Pulmonary Fibrosis in Idiopathic Pulmonary Fibrosis and Non-IPF Interstitial Lung Diseases

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study is a prospective observational study for subjects with idiopathic pulmonary fibrosis (IPF) or non-IPF interstitial lung diseases (ILD). The purpose of this study is to compare whether imaging patterns from high-resolution computed tomography (HRCT) at baseline can predict worsening. Single Time point Prediction (STP) is a score derived from an artificial intelligenc/ machine learning (AI/ML) using the radiomic features from a HRCT scan that quantifies the imaging patterns of short-term predictive worsening.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Established a diagnosis (within 5 years) of IPF by enrolling center as defined by ATS/ERS/JRS/ALAT criteria

• Age over or equal to 40 years old

• No history of lung transplant

• FVC % predicted \>= 45%

• DLCO % predicted \>=25%

• Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.

• Established a diagnosis (within 5 years) of non-IPF ILD by enrolling center.

• Age over or equal to 18 years old

• Presence of chronic fibrosis ILD defined as architectural distortions with reticulation and the presence of traction bronchiectasis estimating visually \>5% in whole lung.

• Patients treated with immunosuppressive agents (other than corticosteroids) for an underlying systemic disease need to be on a stable treatment for at least 12 weeks prior to screening

• FVC % predicted \>= 45%

• DLCO % predicted \>=25%

• Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method

Locations
United States
California
UCLA
RECRUITING
Los Angeles
Contact Information
Primary
Grace Hyun Kim, PhD
GraceKim@mednet.ucla.edu
(310) 481-7594
Backup
Claudia L Perdomo, AS
cperdomo@mednet.ucla.edu
310-267-4707
Time Frame
Start Date: 2024-11-06
Estimated Completion Date: 2028-08-19
Participants
Target number of participants: 200
Treatments
STP >=30%
STP score is 30% or greater than 30% in whole lung at baseline inspirational HRCT scan. STP score is an AL/ML derived score using radiomic patterns of lung parenchyma to identify the spatial location of likely progressed in the short-term follow up. The higher score is the worse expected outcome.
STP < 30%
STP score is less than 30% in whole lung at baseline inspirational HRCT scan.
Sponsors
Collaborators: Boehringer Ingelheim
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov

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