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RECRUITINGOBSERVATIONAL

Single Time Point Prediction as Earlier Diagnosis of Progressive Pulmonary Fibrosis

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

IPF Who May Qualify: - 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. Non-IPF ILD Who May Qualify: - 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 Who Should NOT Join This Trial: - Planned to participate in an intervention trial within the next 6 months - Currently listed for lung transplantation at the time of enrollment - Malignancy, treated or untreated, other than malignancy unlikely to affect prognosis in the next 3 years such as skin cancer or non-metastatic prostate cancer within the past 5 years - Any clinically significant co-morbidity, which in the view of investigator, is likely to contribute to mortality or ability to perform PFT's in the next 2 years - Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) \<0.7 at as screening ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
IPF Inclusion Criteria: * 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. Non-IPF ILD Inclusion Criteria: * 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 Exclusion Criteria: * Planned to participate in an intervention trial within the next 6 months * Currently listed for lung transplantation at the time of enrollment * Malignancy, treated or untreated, other than malignancy unlikely to affect prognosis in the next 3 years such as skin cancer or non-metastatic prostate cancer within the past 5 years * Any clinically significant co-morbidity, which in the view of investigator, is likely to contribute to mortality or ability to perform PFT's in the next 2 years * Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) \<0.7 at as screening * Exclusion of co-morbidities: congestive heart failure (stroke, deep vein thrombosis, pulmonary embolism, myocardial infarction), current virus-associated community acquired pneumonia, smoking-related chronic obstructive lung disease with FEV1 \<70%, history of lung cancer, history of other cancer treated within the past 4 years for IPF and 5 years for non-IPF ILD (excluding basal cell carcinoma of skin). HRCT data from subjects with combined pulmonary fibrosis and emphysema (CPFE) can be collected. Major Discontinuing Criteria in this study * lung transplant after baseline or death * withdraw of consent or transition to another care center

Locations (1)

UCLA
Los Angeles, California, United States