Single Time Point Prediction as Earlier Diagnosis of Progressive Pulmonary Fibrosis

ConditionPulmonary Fibrosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants

are grouped into 2 trial groups

Group A: STP >=30%

Group B: STP < 30%

Trial outcomes

Primary outcomes

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.

Time frame

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

Progression Free Survival (PFS2-PFS6) between the two arms by Single Time point Prediction (STP) score

Four additional PFS definitions will be used to test STP \>=30% or \<30%. * Key Secondary PFS definition (PFS2): same PFS in the primary endpoint for IPF or PPF definition for non-IPF (two events out of three elements in PFT (reduction of 5% or more in % predicted FVC or 10% or more in predicted DLCO if available; radiological worsening; symptomatic worsening); * Secondary PFS definition (PFS3) I: Key Secondary PFS definition (PFS2) convention for non-IPF or annual QLF increase of 2% or higher or visual worsening for IPF; * Secondary PFS definition (PFS4) II: Secondary PFS3 or 6 min walk (decrease of \> 25m in the 6-minute walk distance) or QoL (KBILD of 4-point increase or LCQ SGRQ of 310-point reduction) for both IPF and non-IPF; * Secondary PFS definition (PFS5) III: Secondary PFS 4 or new Oxygen usage or increase in Oxygen usage (\>1L of O2 per min) for both IPF and non-IPF * Secondary PFS definition (PFS6) IV: Secondary PFS2 without acute infection

Time frame

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

Overall Survival will be compared with STP \>=30% or \<30%.

Time frame

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

The 6MWT measures the distance a patient is able to walk quickly on a flat, hard surface in a period of 6 minutes. The 6MW can ranges from 0 m to 1000m. In healthy subjects, the 6MWT ranges from 400m to 700m.

Time frame

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

Progression Free Survival will be compared in subjects with MSGA positive or negative marker.

Time frame

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

Other outcomes

Nasal and Blood Biobanking

The biorepository of nasal and blood samples will be collected for future ancillary study proposal.

Time frame

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

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

Progression Free Survival of IPF and non-IPF ILD will be compared in patients with a various threshold of STP 20% to 50%

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Boehringer Ingelheim

Collaborator

Source ClinicalTrials.gov

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