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Xenon MRI for Idiopathic Pulmonary Fibrosis
Phase 2
Waitlist Available
Led By Robert Tighe, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of IPF confirmed by multidisciplinary diagnosis and naïve to treatment with an approved IPF therapy (either nintedanib or pirfenidone)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pulmonary function testing will occur prior to initiation of therapy and then at 3, 6 and 12 months following initiation of therapy.
Awards & highlights
Study Summary
This trial is being done to see if 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.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if MRI scans using hyperpolarized 129 Xenon gas can track lung function changes in IPF patients over time compared to standard treatments. Participants will undergo MRIs before starting therapy and at intervals up to one year after beginning treatment.See study design
What are the potential side effects?
Risks from the MRI are minimal as it uses magnetism and radio waves without reported ill effects. The xenon gas may cause slight numbness in legs, nausea, euphoria, and mild tingling in fingertips. Breathlessness or dizziness might occur during pulmonary function testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with IPF and have not started treatment with nintedanib or pirfenidone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the rbc:barrier measure will be assessed at time of study enrollment and then at 3, 6 and 12 months following initiation of ipf therapy.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the rbc:barrier measure will be assessed at time of study enrollment and then at 3, 6 and 12 months following initiation of ipf therapy.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy
Secondary outcome measures
Change in Pulmonary Function Following Initiation of IPF therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)Experimental Treatment1 Intervention
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
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,367 Previous Clinical Trials
3,424,827 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
2,443 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Robert Tighe, MDPrincipal InvestigatorDuke University Health Systems
3 Previous Clinical Trials
136 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old and not hospitalized.I have been diagnosed with IPF and have not started treatment with nintedanib or pirfenidone.I have had a heart rhythm problem in the last month.I haven't had a lung infection in the last 30 days.I had a cardiac arrest in the past year.I needed antibiotics or steroids for a flare-up in the last 30 days.I have taken pirfenidone or nintedanib before.My oxygen levels are below 90% even with extra oxygen.You cannot fit into the 129 Xenon vest coil used for MRI.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA sanction the use of Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment?
"While there is some evidence that hyperpolarized 129 xenon gas is safe, it has not been proven effective in treating idiopathic pulmonary fibrosis. Therefore, our team at Power gives it a 2."
Answered by AI
Are new volunteers needed for this clinical trial?
"Yes, this trial is still recruiting patients. The posting on clinicaltrials.gov shows that the study was originally published on August 3rd 2020 and has been edited as recently as May 3rd 2022."
Answered by AI
Are there other instances of using Hyperpolarized 129 Xenon Gas to study potential treatments for Idiopathic Pulmonary Fibrosis?
"There are a total of 15 ongoing clinical trials researching Hyperpolarized 129 Xenon Gas Comparing Idiopathic pulmonary fibrosis (IPF) Treatment. 0 of these active trials are in Phase 3, with the majority based in Philadelphia, Pennsylvania. In total, there 21 locations running trials for this treatment worldwide."
Answered by AI
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