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Xenon MRI for Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen byRobert M Tighe, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Duke University

Must not be taking: Nintedanib, Pirfenidone

Disqualifiers: Pregnancy, Cardiac arrhythmia, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, certain immunosuppressive medications are allowed if your doctor agrees.

What data supports the effectiveness of the treatment Hyperpolarized 129 Xenon Gas for Pulmonary Fibrosis?

Research shows that Hyperpolarized 129 Xenon MRI is a promising tool for assessing lung function, as it can evaluate ventilation and gas transfer in the lungs. This imaging technique has been used to study various lung conditions, suggesting its potential usefulness in managing pulmonary fibrosis by providing detailed insights into lung physiology.¹ ² ³ ⁴ ⁵

How does Xenon MRI differ from other treatments for pulmonary fibrosis?

Xenon MRI is unique because it uses hyperpolarized xenon gas to create detailed images of lung function, allowing doctors to assess both ventilation and gas transfer in the lungs. Unlike traditional treatments that focus on managing symptoms, this imaging technique provides a non-invasive way to understand lung physiology and track disease progression.¹ ³ ⁴ ⁵ ⁶

Research Team

Robert M Tighe, MD

Principal Investigator

Duke University Health Systems

Eligibility Criteria

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.

Inclusion Criteria

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

My doctor approves of my immunosuppressive medication use.

My lung condition has worsened in the last 2 years.

See 1 more

Exclusion Criteria

Subject deemed unlikely to be able to comply with instructions during imaging

I have previously been treated with nintedanib or pirfenidone.

I had a cardiac arrest in the last year.

See 9 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline MRI and Initial Assessment

Subjects undergo a comprehensive MRI protocol including administration of multiple doses of hyperpolarized 129Xe prior to initiation of anti-fibrotic therapies.

1 day

1 visit (in-person)

Treatment and Monitoring

Participants receive anti-fibrotic therapy and undergo repeat MRI studies at 3, 6, and 12 months following the initiation of therapy. Additional studies include pulmonary function tests, biomarker analysis, and HRCT at specified intervals.

12 months

3 visits (in-person) at 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment through periodic reviews of the medical record.

6 months

Treatment Details

Interventions

Hyperpolarized 129 Xenon Gas (Gas)

Trial OverviewThe 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.

Participant Groups

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.