Single Time Point Prediction as Earlier Diagnosis of Progressive Pulmonary Fibrosis

NCT06162884 | Recruiting

• 2 other identifiers: IRB#23-001246ECR2022-3630
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Fibrosis

Keywords

imaging outcome; Single Timepoint Prediction; AI/machine learning; progressive ILD

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) between the two arms by Single Time point Prediction (STP) score

  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.

  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

Secondary Outcomes (5)

• 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)

Other Outcomes (2)

• Nasal and Blood Biobanking

  At baseline (or screening) and year 1 follow-up

• Estimate median PFS by the levels of STP ranging 20% to 50%

  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

Study Arms (2)

STP >=30%

STP score is 30% or greater than 30% in whole lung at baseline inspirational HRCT scan. STP score is an AL/ML derived score using radiomic patterns of lung parenchyma to identify the spatial location of likely progressed in the short-term follow up. The higher score is the worse expected outcome.

STP < 30%

STP score is less than 30% in whole lung at baseline inspirational HRCT scan.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary objective is to predict early for progression in both IPF and non-IPF ILD population using a new artificial intelligence machine learning (AI/ML) algorithm of Single Timepoint Prediction (STP) score from HRCT. The primary interest is to validate STP score in identifying cohort early for the candidate of anti-fibrotic treatment.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90024, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Medical imaging CT images will divide two arms of high STP and low STP groups using a threshold of 30% STP score. Blood collection: CPT, EDTA, Blood RNA and SST Nasal Swab: 2 nasal swabs

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Weigt, MD

  UCLA Division of Pulmonary, Critical Care, and Hospitals

  PRINCIPAL INVESTIGATOR

• Jonathan Goldin, MD

  Radiological Sciences at the University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Hyun Kim, PhD

CONTACT

(310) 481-7594; GraceKim@mednet.ucla.edu

Claudia L Perdomo, AS

CONTACT

310-267-4707; cperdomo@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: November 6, 2024
• Primary Completion (Estimated): November 22, 2027
• Study Completion (Estimated): August 19, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (1)