Xenon MRI for Pulmonary Fibrosis

Overseen By Claudia Salazar

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must not be taking: Nintedanib, Pirfenidone

Disqualifiers: Pregnancy, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

75 Participants Needed

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.

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.

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

Trial Overview 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.

Participant Groups

Group I: Progressive Pulmonary Fibrosis Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Findings from Research

Hyperpolarized (HP) noble gas MRI, particularly using 129Xe, has shown promising results in assessing lung ventilation and regional lung physiology, making it a potential game-changer in pulmonary medicine.

Despite being limited to select academic institutions currently, advancements in polarizer technology suggest that HP 129Xe MRI could soon become more widely available for clinical use, enhancing the diagnostic capabilities for lung conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of hyperpolarized 129xenon in MR imaging of pulmonary function. Ebner, L., Kammerman, J., Driehuys, B., et al.[2018]

Hyperpolarized noble gas MRI using helium-3 or xenon-129 enhances MRI signal, making it a promising method for imaging lung function and ventilation.

While there are safety considerations and challenges in clinical application, this technology holds potential for better understanding lung microstructure and function in various pulmonary diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. Liu, Z., Araki, T., Okajima, Y., et al.[2017]

The study involving 13 healthy volunteers demonstrated that MRI measurements of gas exchange using hyperpolarized 129 Xenon show good repeatability, particularly for the RBC:Barrier ratio, which had a high intraclass correlation coefficient of 0.92.

The RBC:Barrier ratio was strongly correlated with intervisit changes in DLCO, indicating its potential as a reliable imaging biomarker for assessing pulmonary function, independent of lung inflation volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. Hahn, AD., Kammerman, J., Evans, M., et al.[2020]

Hyperpolarized 129Xe MRI (HypX-MRI) shows great promise as a new diagnostic tool, enhancing the detectability of lung structures and potentially allowing for better imaging of lipid-rich tissues, which has been challenging with traditional methods.

This technique could help identify issues like ventilation-perfusion mismatch in pulmonary diseases and may also be used for functional MRI studies of the brain, opening new avenues for understanding lung function and brain perfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. Albert, MS., Balamore, D.[2019]

Hyperpolarized 129 Xenon-MRI (HP 129 Xe MRI) is a new imaging technique that can assess both how well air moves in and out of the lungs (ventilation) and how effectively gases are transferred in the lungs.

While most studies have focused on non-cancer lung diseases, HP 129 Xe MRI shows great potential for improving the management and understanding of lung cancer by evaluating these key lung functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. Song, EJ., Kelsey, CR., Driehuys, B., et al.[2022]

A new continuous-flow system for producing hyperpolarized xenon (129Xe) has been developed, achieving production rates of 0.3 liters per hour with 64% polarization, significantly improving the availability of this imaging agent for lung MRI studies.

This technology allows for the production of multiliter quantities of hyperpolarized xenon several times daily, enabling more extensive human lung imaging studies that were previously limited by the availability of hyperpolarized gas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large production system for hyperpolarized 129Xe for human lung imaging studies. Hersman, FW., Ruset, IC., Ketel, S., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

The role of hyperpolarized 129xenon in MR imaging of pulmonary function. [2018]

2. Ireland pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Large production system for hyperpolarized 129Xe for human lung imaging studies. [2022]