Xenon MRI for Idiopathic Pulmonary Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is being done to determine whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments.Subjects will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyper-polarized 129 Xenon. The subjects will have this initial study prior to initiation of IPF therapies. Then the subjects will have repeat studies at 3, 6 and 12 months following the initiation of therapy. Additional studies including pulmonary function studies, serum for bio markers, 6 minute walk distance and a high-resolution computed tomography (HRCT) scan (only at the 6 month visit) will be performed to determine how 129 Xenon MRI performs relative to standard of care evaluations for IPF.The MRI uses a magnet and radio waves to make diagnostic medical images of the body. There have been no ill effects reported from exposure to the magnetism or radio waves used in this test. Risks of the xenon gas are slight numbness in legs, nausea, a feeling of well-being, and mild tingling in fingertips. You will have pulmonary function testing for the study, you may experience breathlessness or dizziness during or immediately following these tests.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires participants to be new to IPF treatments like nintedanib or pirfenidone.
Is hyperpolarized 129 Xenon gas safe for use in humans?
How does Xenon MRI differ from other treatments for idiopathic pulmonary fibrosis?
Xenon MRI is unique because it uses hyperpolarized xenon-129 gas as a contrast agent to provide detailed images of lung function, specifically assessing ventilation and gas transfer, which is not possible with standard imaging techniques. This approach offers a novel way to evaluate lung physiology in patients with idiopathic pulmonary fibrosis, potentially identifying issues that other treatments might miss.15678
What data supports the effectiveness of the treatment Hyperpolarized 129 Xenon Gas for idiopathic pulmonary fibrosis?
Research shows that Hyperpolarized 129 Xenon MRI can effectively image lung function and detect impaired lung physiology in idiopathic pulmonary fibrosis (IPF). It provides detailed images of how gas moves through the lungs, which can help monitor disease progression and assess treatment response.148910
Who Is on the Research Team?
Robert Tighe, MD
Principal Investigator
Duke University Health Systems
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a clinical diagnosis of Idiopathic Pulmonary Fibrosis (IPF) who haven't started treatment. They must be able to consent and follow the study schedule. People can't join if they don't fit in the MRI coil, have had cardiac issues or severe respiratory illness recently, are pregnant, need supplemental oxygen, or have conditions affecting their ability to participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline MRI
Participants undergo a comprehensive MRI protocol using hyper-polarized 129 Xenon gas prior to initiation of IPF therapies
Treatment and Monitoring
Participants receive approved IPF treatments and undergo repeat MRI studies at 3, 6, and 12 months, along with additional pulmonary function studies and biomarker assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hyperpolarized 129 Xenon Gas
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor