NCT06162884Recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Observational
Enrollment: 200 (estimated)
First submitted: 30 Nov 2023
Start date: 6 Nov 2024
Primary completion date: 22 Nov 2028
Lead sponsor: University of California, Los Angeles
Diseases: Idiopathic pulmonary fibrosis
NCT number: NCT06162884

What you commit to

Study type: Observational
Planned participants: 200
From 6 Nov 2024 to the primary completion date, 22 Nov 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Currently listed for lung transplantation at the time of enrollment
lung transplant after baseline or death

Other illness

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
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

Other

Planned to participate in an intervention trial within the next 6 months
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
withdraw of consent or transition to another care center

Criteria the registry did not label

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
UCLA Coordinator of this site? Confirm its status	Los Angeles	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.