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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

Must not have

Respiratory illness of a bacterial or viral etiology within 30 days of MRI

Subject has history of cardiac arrest within the last year

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

No Placebo-Only Group

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.

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.

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 below

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I have been diagnosed with IPF and have not started treatment with nintedanib or pirfenidone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a lung infection in the last 30 days.

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I had a cardiac arrest in the past year.

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I needed antibiotics or steroids for a flare-up in the last 30 days.

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I have taken pirfenidone or nintedanib before.

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My oxygen levels are below 90% even with extra oxygen.

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I am under 18 years old.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy

Secondary study objectives

Change in Pulmonary Function Following Initiation of IPF therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met