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Xenon MRI for Pulmonary Fibrosis

Phase 2

Recruiting

Led By Robert M 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

Patients must be over 18 years of age with a physician-diagnosed ILD of specified subtypes based on multidisciplinary consensus

Be older than 18 years old

Must not have

Prior treatment with nintedanib or pirfenidone

Subject has history of cardiac arrest within the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the use of hyperpolarized 129Xe MRI to see how well it works in patients with non-idiopathic pulmonary fibrosis or progressive fibrosis interstitial lung disease.

Who is the study for?

This trial is for adults over 18 with physician-diagnosed progressive fibrosis interstitial lung disease (ILD) who have shown signs of the disease getting worse in the last 24 months. They must be able to consent and follow the study plan. People can't join if they've had certain respiratory illnesses recently, previous treatments with specific anti-fibrotic drugs, or are pregnant.

What is being tested?

The study at Duke University tests how well hyperpolarized 129 Xenon Gas MRI works in monitoring ILD progression before and after starting anti-fibrotic therapy. Participants will undergo MRIs prior to treatment and then again at 3, 6, and 12 months into their therapy.

What are the potential side effects?

Since this trial involves MRI scans using a special gas called hyperpolarized Xenon, side effects might include discomfort from lying still during the scan or reactions related to inhaling the gas; however, these potential side effects are not extensively detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and have been diagnosed with a specific type of lung disease.

Exclusion Criteria

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

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I have previously been treated with nintedanib or pirfenidone.

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I had a cardiac arrest in the last year.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months 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 129Xe MRI barrier uptake 3 months after anti-fibrotic initiation

Secondary study objectives

Change in 129Xe MRI RBC to barrier ratio 3 months after anti-fibrotic initiation

Change in 129Xe MRI RBC to barrier ratio 6 months after anti-fibrotic initiation

Change in 129Xe MRI barrier uptake 6 months after anti-fibrotic initiation

+5 more

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: Progressive Pulmonary FibrosisExperimental 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 Progressive Pulmonary Fibrosis patients receiving approved treatments.

0 / 4Eligibility criteria met