Actively Recruiting
Single Time Point Prediction as Earlier Diagnosis of Progressive Pulmonary Fibrosis
Led by University of California, Los Angeles · Updated on 2025-06-15
200
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Single Time Point Prediction as Earlier Diagnosis of Progressive Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For IPF: diagnosis within 5 years by ATS/ERS/JRS/ALAT criteria
- For IPF: age 40 years or older
- For IPF: no history of lung transplant
- For IPF: FVC predicted 45% or higher
- For IPF: DLCO predicted 25% or higher
- For IPF: women of childbearing potential must use highly effective birth control and a barrier method if using oral contraceptives
- For non-IPF ILD: diagnosis within 5 years
- For non-IPF ILD: age 18 years or older
- For non-IPF ILD: chronic fibrosis with lung distortions and traction bronchiectasis affecting more than 5% of the lungs
- For non-IPF ILD: stable immunosuppressive treatment for at least 12 weeks if used
- For non-IPF ILD: FVC predicted 45% or higher
- For non-IPF ILD: DLCO predicted 25% or higher
- For non-IPF ILD: women of childbearing potential must use highly effective birth control and a barrier method if using oral contraceptives
You will not qualify if you...
- Planned participation in an intervention trial within 6 months
- Currently listed for lung transplantation
- Malignancy likely to affect prognosis within 3 years, except certain skin or non-metastatic prostate cancers
- Clinically significant co-morbidity likely to affect mortality or pulmonary function testing in 2 years
- Prebronchodilator FEV1/FVC ratio less than 0.7 at screening
- Congestive heart failure or related serious conditions
- Current virus-associated community acquired pneumonia
- Smoking-related COPD with FEV1 less than 70%
- History of lung cancer or other cancer treated within last 4 years for IPF and 5 years for non-IPF ILD (except basal cell skin cancer)
- Major discontinuing criteria: lung transplant after baseline, death, withdrawal of consent, or transition to another care center
AI-Screening
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Trial Site Locations
Total: 1 location
1
UCLA
Los Angeles, California, United States, 90024
Actively Recruiting
Research Team
G
Grace Hyun Kim, PhD
CONTACT
C
Claudia L Perdomo, AS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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