Xenon MRI and Progressive ILD

NCT05241275 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro00109322
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The XENON ILD study is a single arm, un-blinded study at Duke University enrolling patients with non-idiopathic pulmonary fibrosis (IPF) progressive fibrosis (PF) interstitial lung disease (ILD). Patients who meet criteria for ILD-progression (defined below in inclusion/exclusion criteria) will be consented prior to the initiation of anti-fibrotic therapy. Subjects will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyperpolarized 129Xe. The subjects will have this initial study prior to initiation of anti-fibrotic therapies and repeat MRI studies at 3, 6 and 12 months following the initiation of therapy. If subjects do not decide to initiate anti-fibrotic therapy per discussion with their physician, then the 3, 6 and 12 months repeat studies will initiate based on time after enrollment.

Conditions

Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis

Keywords

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Change in 129Xe MRI barrier uptake 3 months after anti-fibrotic initiation

  The outcome will assess changes in 129Xe MRI barrier uptake 3 months after nintedanib initiation.

  Baseline, 3 months

Secondary Outcomes (8)

• Change in 129Xe MRI barrier uptake 6 months after anti-fibrotic initiation

  Baseline and 6 months

• Change in 129Xe MRI RBC to barrier ratio 3 months after anti-fibrotic initiation

  Baseline and 3 months

• Change in 129Xe MRI RBC to barrier ratio 6 months after anti-fibrotic initiation

  Baseline and 6 months

• Time to disease progression (occurrence of a ≥ 10% drop in percent predicted FVC, all cause death, or lung transplant) in individuals with elevated barrier uptake at baseline greater than 2 standard deviations of a healthy reference cohort

  Up to 12 months

• Time to disease progression (occurrence of a ≥ 10% drop in percent predicted FVC, all cause death, or lung transplant) in individuals with decreased RBC transfer at baseline, lower than 2 standard deviations of a healthy reference cohort

  Up to 12 months

Study Arms (1)

Progressive Pulmonary Fibrosis

EXPERIMENTAL

Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis patients receiving approved treatments.

Drug: Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis Treatment

Interventions

Hyperpolarized 129 Xenon Gas Comparing Progressive Pulmonary Fibrosis Treatment DRUG

Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Progressive Pulmonary Fibrosis

Progressive Pulmonary Fibrosis

Eligibility Criteria

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

You may qualify if:

• We will include all patients who are over 18 years of age with a physician-diagnosed ILD of one of the below subtypes based on multidisciplinary consensus
• Chronic hypersensitivity pneumonitis
• Autoimmune interstitial lung disease (including rheumatoid arthritis-ILD, mixed connective tissue disorder related ILD, myositis related ILD, scleroderma related ILD, and idiopathic pneumonia with autoimmune features)
• Idiopathic NSIP
• Unclassifiable idiopathic interstitial pneumonia
• Fibrotic lung disease affecting more than 10% of lung volume on high-resolution CT, per Duke radiology review
• Evidence of any of the following criteria for progression of ILD within the 24 months before screening:
• Relative decline in FVC % predicted of at least 10%
• Relative decline in FVC % predicted ≥ 5% - \< 10 combined with either increasing extent of fibrotic changes on HRCT or worsening of respiratory symptoms
• Worsening respiratory symptoms and increased extent of fibrosis on HRCT
• Willing and able to give informed consent and adhere to visit/protocol schedules
• Immunosuppressive medication, including azathioprine, cyclosporine, mycophenolate mofetil, rituximab, cyclophosphamide, or oral glucocorticoids are permitted at the discretion of the treating physician

You may not qualify if:

• Subject is less than 18 years of age
• Prior treatment with nintedanib or pirfenidone
• Subject is pregnant or lactating
• Prior investigational drug use within 28 days
• MRI is contraindicated based on responses to MRI screening questionnaire
• Respiratory illness of a bacterial or viral etiology within 30 days of MRI
• Acute exacerbation within 30 days of MRI, defined by acute increases in oxygen requirement, bilateral alveolar filling opacities on imaging, and the need for antibiotics and/or systemic steroids
• Subject does not fit into 129Xe vest coil used for MRI
• Subject with ventricular cardiac arrhythmia in the past 30 days.
• Subject has history of cardiac arrest within the last year
• Subject deemed unlikely to be able to comply with instructions during imaging
• Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Sponsors & Collaborators

• Duke University: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert M Tighe, MD

  Duke University Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 15, 2022
• Study Start: July 19, 2022
• Primary Completion: November 3, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)