Using Xenon MRI to assess progressive lung disease
XENON ILD: 129Xe MRI to Evaluate aNtifibrotic respOnse and progressioN in ILD
This study is testing a special type of MRI to see how well it can track the progress of lung disease in patients who are starting new treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | rituximab, cyclophosphamide |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05241275 on ClinicalTrials.gov |
What this trial studies
The XENON ILD study is an interventional trial at Duke University focusing on patients with progressive interstitial lung disease (ILD) who are candidates for anti-fibrotic therapy. Participants will undergo a comprehensive MRI protocol using hyperpolarized 129Xe before starting treatment, with follow-up MRI scans at 3, 6, and 12 months to monitor disease progression. The study aims to enroll 75 subjects, ensuring that at least 38 begin anti-fibrotic therapy after the initial MRI. Additional assessments will include pulmonary function tests and biomarker analysis to enhance understanding of ILD progression.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a physician-diagnosed progressive interstitial lung disease and evidence of disease progression.
Not a fit: Patients with stable ILD or those not meeting the criteria for disease progression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and treatment outcomes for patients with progressive pulmonary fibrosis.
How similar studies have performed: Other studies using hyperpolarized gas MRI have shown promise in assessing lung diseases, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 1. Chronic hypersensitivity pneumonitis 2. 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) 3. Idiopathic NSIP 4. 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: 1. Relative decline in FVC % predicted of at least 10% 2. Relative decline in FVC % predicted ≥ 5% - \< 10 combined with either increasing extent of fibrotic changes on HRCT or worsening of respiratory symptoms 3. 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 Exclusion Criteria: * 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
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Robert M Tighe, MD — Duke University Health Systems
- Study coordinator: Claudia Salazar
- Email: claudia.salazar@duke.edu
- Phone: 9196602026
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.