NCT05241275Active, not recruitingPhase 2
Xenon MRI and Progressive ILD
XENON ILD: 129Xe MRI to Evaluate aNtifibrotic respOnse and progressioN in ILD
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 3 Feb 2022
- Start date
- 19 Jul 2022
- Primary completion date
- 3 Nov 2025
- Lead sponsor
- Duke University
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT05241275
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From 19 Jul 2022 to the primary completion date, 3 Nov 2025
- 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
- Prior treatment with nintedanib or pirfenidone
- Prior investigational drug use within 28 days
- 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
Other illness
- Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- Subject with ventricular cardiac arrhythmia in the past 30 days.
- Subject has history of cardiac arrest within the last year
- 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
Age
- Subject is less than 18 years of age
Other
- Subject is pregnant or lactating
- MRI is contraindicated based on responses to MRI screening questionnaire
- Subject does not fit into 129Xe vest coil used for MRI
- Subject deemed unlikely to be able to comply with instructions during imaging
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.