Single Time Point Prediction as Earlier Diagnosis of Progressive Pulmonary Fibrosis

About

Brief 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.

Study Type

Observational

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

IPF Inclusion Criteria:

Established a diagnosis (within 3 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%

Non-IPF ILD Inclusion Criteria:

Established a diagnosis (within 3 years) of IPF 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 >10% in whole lung.
FVC % predicted >= 45%
DLCO % predicted >=25%

Exclusion Criteria:

Planned to participate an intervention trial within the next 3 months
Currently listed for lung transplantation at the time of enrollment
Malignancy, treated or untreated, other than skin cancer or prostate cancer within the past 5 years
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 (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

Not a fit? Find another study