Predicting worsening of pulmonary fibrosis using AI from CT scans
Imaging Signature of Progressive Pulmonary Fibrosis in Idiopathic Pulmonary Fibrosis and Non-IPF Interstitial Lung Diseases
This study is testing if using AI to analyze CT scans can help predict which patients with pulmonary fibrosis are likely to get worse over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06162884 on ClinicalTrials.gov |
What this trial studies
This observational study aims to predict the progression of idiopathic pulmonary fibrosis (IPF) and non-IP interstitial lung diseases (ILD) by analyzing high-resolution computed tomography (HRCT) scans. Using an artificial intelligence and machine learning approach, the study will derive a Single Time Point Prediction (STP) score from baseline HRCT images to identify patients at risk of worsening disease. Participants will be grouped based on their STP scores, and clinical data such as pulmonary function tests and symptom scores will be collected to validate the predictive capability of the STP score. The study does not involve any intervention and will be conducted at the UCLA ILD Center.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of IPF or non-IP ILD and specific pulmonary function criteria.
Not a fit: Patients with a history of lung transplantation or those currently participating in an intervention trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable earlier identification of patients who may benefit from anti-fibrotic treatments.
How similar studies have performed: While the use of AI in imaging for disease prediction is a growing field, this specific approach using STP scores in pulmonary fibrosis is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- UCLA — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Samuel Weigt, MD — UCLA Division of Pulmonary, Critical Care, and Hospitals
- Study coordinator: Grace Hyun Kim, PhD
- Email: GraceKim@mednet.ucla.edu
- Phone: (310) 481-7594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.