Xenon MRI for Idiopathic Pulmonary Fibrosis

Overseen By Matthew P Kummerer, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must not be taking: Pirfenidone, Nintedanib

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: 4

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to track lung function in individuals with Idiopathic Pulmonary Fibrosis (IPF), a condition that makes breathing difficult. It employs a special MRI scan with inhaled hyperpolarized 129 xenon gas to assess lung function before and during treatment. The aim is to determine if this method better reveals changes in lung health over time. Individuals recently diagnosed with IPF who have not yet started treatment might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in IPF care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to be new to IPF treatments like nintedanib or pirfenidone.

What prior data suggests that this MRI protocol using hyperpolarized 129 Xenon gas is safe for IPF patients?

Research has shown that using hyperpolarized 129 Xenon gas in MRI scans is generally safe. In studies with healthy volunteers and patients with lung conditions, participants tolerated the procedure well. Some reported mild numbness in their legs, nausea, a sense of well-being, or slight tingling in their fingertips. These effects were minor and temporary.

No serious issues have been linked to the MRI process itself, which uses magnets and radio waves to capture images of the lungs. This imaging method aids doctors in understanding lung diseases better. Overall, evidence suggests that the procedure is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hyperpolarized 129 Xenon gas for Idiopathic Pulmonary Fibrosis (IPF) because it offers a novel way to visualize lung function. Unlike standard treatments that primarily manage symptoms and slow disease progression, this approach uses a special type of MRI to directly observe changes in lung function over time. This technique could lead to earlier and more precise detection of lung impairments, potentially allowing for better monitoring of how patients respond to existing IPF therapies.

What evidence suggests that this MRI technique is effective for visualizing lung function in IPF?

Research has shown that hyperpolarized 129 Xenon gas MRI can effectively detect changes in lung function for people with idiopathic pulmonary fibrosis (IPF). In this trial, participants will undergo MRI using inhaled hyperpolarized 129 Xenon gas to visualize impaired lung function and detect changes over time. This imaging technique is sensitive to areas of the lungs that aren't working properly and has also identified improvements in patients who took antifibrotic medications for a year. The MRI provides clear images of both small airways and lung tissue, which is crucial for monitoring the progression of IPF. This method could be a valuable tool for assessing the effectiveness of IPF treatments over time. ^{1 3 5 6 7}

Who Is on the Research Team?

Robert Tighe, MD

Principal Investigator

Duke University Health Systems

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)

Exclusion Criteria

I have had a heart rhythm problem in the last month.

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

Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline MRI

Participants undergo a comprehensive MRI protocol using hyper-polarized 129 Xenon gas prior to initiation of IPF therapies

1 hour

1 visit (in-person)

Treatment and Monitoring

Participants receive approved IPF treatments and undergo repeat MRI studies at 3, 6, and 12 months, along with additional pulmonary function studies and biomarker assessments

12 months

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

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 129 Xenon Gas

Trial Overview 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.

How Is the Trial Designed?

Group I: Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) 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 Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

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]

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]

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]

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 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]

Inhalation of hyperpolarized (129)Xe gas was well tolerated among 42 participants, including healthy individuals and those with various pulmonary diseases, with only two mild adverse events reported, indicating a strong safety profile.

The study showed that while there were statistically significant changes in oxygen saturation and heart rate after inhalation, these changes were clinically insignificant and resolved quickly, suggesting that (129)Xe inhalation is safe for use in both healthy and diseased lungs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 129Xe magnetic resonance imaging: tolerability in healthy volunteers and subjects with pulmonary disease. Shukla, Y., Wheatley, A., Kirby, M., et al.[2022]

Hyperpolarized xenon-129 MRI detected significant lung function impairments in patients with usual interstitial pneumonia (UIP), showing a ventilation defect fraction of 30% compared to 21% in healthy controls, indicating its efficacy in identifying lung abnormalities.

The MRI also revealed elevated levels of xenon dissolved in the lung interstitium in UIP patients, which could serve as an early indicator of lung fibrosis, even when traditional pulmonary function tests showed normal or mild impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary Physiology in Patients with Pulmonary Fibrosis. Qing, K., Altes, TA., Mugler, JP., et al.[2023]

Hyperpolarized 129Xe MRI effectively identifies functional impairment in patients with idiopathic pulmonary fibrosis (IPF), showing a significant increase in barrier uptake compared to healthy individuals, indicating its potential as a diagnostic tool.

The MRI metrics correlated strongly with pulmonary function tests (PFTs) but poorly with CT fibrosis scores, suggesting that 129Xe MRI may provide a more accurate assessment of lung function and disease progression in IPF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using hyperpolarized 129Xe MRI to quantify regional gas transfer in idiopathic pulmonary fibrosis. Wang, JM., Robertson, SH., Wang, Z., et al.[2018]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10294784/

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary ... Conclusion: The hyperpolarized 129Xe MRI was highly sensitive to regional functional changes in subjects with UIP and may represent a new tool ...

2. mdpi.com mdpi.com/2075-4418/15/4/474

Hyperpolarized Xenon-129 MRI: Narrative Review of ... Publications using 129XeMRI to assess clinical observations or outcomes in pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.211433

Hyperpolarized 129 Xe MR Spectroscopy in the Lung ... In a prospective study, reduced lung function at hyperpolarized 129 Xe MRI and extent of fibrotic structure at CT were associated with disease progression.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10291299/

Functional xenon-129 magnetic resonance imaging ... A measure of regional gas exchange on HP 129 Xe MRI was able to detect apparent improvements in IPF patients treated with antifibrotic medication after 1 year.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666675824001589

Direct imaging of pulmonary gas exchange with ... Hyperpolarized 129Xe gas MRI has shown significant promise in detecting and evaluating abnormalities in pulmonary small airways, parenchyma, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3244666/

Safety and Tolerability of Hyperpolarized 129Xe MR ... Chronic Obstructive Pulmonary Disease: Safety and Tolerability of Hyperpolarized 129 Xe MR Imaging in Healthy Volunteers and Patients

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1090780723000228

Hyperpolarized 129Xe MRI at low field: Current status and ... Hyperpolarized 129Xe MRI permits high-sensitivity in-vivo imaging of human lungs. · Improved SNR and longer T2* at low field suggests optimum field strength ...