Imaging Signature of Progressive Pulmonary Fibrosis in Idiopathic Pulmonary Fibrosis and Non-IPF Interstitial Lung Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS) between the two arms by Single Time point Prediction (STP) score
研究概览
简要总结
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.
详细描述
Primary objective is to predict early for progression in both IPF and non-IPF ILD population using an artificial intelligence (AI)/Machine Learning (ML) algorithm of STP score. The primary interest is to validate STP score in identifying a cohort early for the candidate of anti-fibrotic treatment. The study plans to collect clinical information such as pulmonary function tests (PFT), symptom scores, 6-minute walk tests (6MWT), and radiologic information from HRCT. This study does not intervene with patient's standard medical care.
This proposal is a prospective study that will enroll patients from the UCLA ILD Center. STP scores of subjects' baseline HRCT images will be grouped to one of 2 arms based on the baseline HRCT.
- Arm A: STP>=30% in whole lung
- Arm B: STP < 30% in whole lung
A subject's allocation will be determined by the baseline HRCT scan. STP score will be derived from the baseline HRCT to compare the early prediction of progression in ILD, STP of 30% threshold is expected to be close to the mean of overall population. In addition, a multi-scale guided attention (MSGA) is an imaging marker from deep learning model with two attention models to classify an IPF-likeliness using HRCT.
Primary endpoint of progression-free survival (PFS) is uniformly defined in IPF and non-IPD ILD subjects by the reduction of 10% or more by FVC in volume or 15% or more by DLCO or death from any cause, whichever came first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 by visual assessment: (1) estimating visually >5% in whole lung, or (2) mild pulmonary fibrosis and <5% in whole lung (i.e., early non-IPF-ILD identified by a pulmonologist).
- •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
排除标准
- •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
结局指标
主要结局
Progression Free Survival (PFS) between the two arms by Single Time point Prediction (STP) score
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
PFS of IPF and non-IPF ILD will be compared in patients with STP \>=30% or \<30%. A higher STP score, ranging from 0% to 100%, indicates a worse outcome. Progression is uniformly defined in both IPF and non-IPF ILD population as the reduction of FVC \>=10% or the reduction of DLCO \>=15% or death due to the disease.
次要结局
- Progression Free Survival (PFS2-PFS5) between the two arms by Single Time point Prediction (STP) score(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.)
- Overall Survival (OS) between the two arms by Single Time point Prediction (STP) score(From date of randomization until the date of death from any cause, assessed up to 3 years.)
- Changes in Distance Walked (Meters, m) on the 6-Minute Walk Test (6MWT) by two arms of STP score(From Baseline in every 3-6-month to end of the study (up to 2 years))
- PFS between two arms by Multi-Scale Guided Attention (MSGA) marker(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
- OS between two arms by Multi-Scale Guided Attention (MSGA) marker(From Baseline to end of the study (up to 3 years))
研究者
Grace Hyun Kim
Principal Investigator
University of California, Los Angeles