Xenon-129 MRI for Pulmonary Disease

Overseen By Sharon Braganza, BSc

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: The Hospital for Sick Children

Disqualifiers: Cardiovascular disorders, Respiratory infection, Pregnancy, 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

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special lung imaging technique using Xenon-129 and a fluorinated gas to assess lung structure and function in individuals with cystic fibrosis and asthma. The researchers aim to compare these images with those from healthy individuals to gain a better understanding of these lung conditions. It suits individuals 8 years or older who have cystic fibrosis or asthma, do not smoke, and have stable symptoms. Participants must hold their breath for about 20 seconds during the MRI. As a Phase 2 trial, this research focuses on evaluating the imaging technique's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this imaging technique is safe for lung evaluation?

Research has shown that using hyperpolarized Xenon-129 for MRI lung scans is generally safe. The FDA has approved a gas mix called XENOVIEW, which includes Xenon-129, for assessing lung function, indicating its safety. Although studies using Xenon-129 MRI have not specifically focused on safety, they have not reported any negative effects.

In this trial, participants will inhale Xenon-129 along with perfluoropropane, another gas used for imaging. The use of Xenon-129 in medical settings for lung scans, combined with the absence of reported side effects in research, suggests it is likely safe for individuals with conditions like cystic fibrosis and asthma, as well as for healthy individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Xenon-129 MRI for pulmonary diseases because it offers a unique way to visualize lung function. Unlike traditional imaging techniques, Xenon-129 acts as a contrast agent that highlights how air moves through the lungs, providing a detailed picture of lung ventilation. This method is non-invasive and uses hyperpolarized gas, which makes it safe and comfortable for patients. By offering more precise imaging, it could potentially lead to better diagnosis and monitoring of lung conditions like cystic fibrosis and asthma, improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for cystic fibrosis and asthma?

Studies have shown that Xenon-129 MRI, which participants in this trial will undergo, serves as a powerful tool for examining lung function and appearance. It has been used successfully for conditions like chronic obstructive pulmonary disease (COPD) and asthma. Research indicates it can clearly display air movement through the lungs and gas exchange efficiency. Specifically, one study found a 42.1% improvement in image clarity. This makes Xenon-129 MRI a promising method for evaluating lung diseases like cystic fibrosis and asthma. ^{5 6 7 8 9}

Who Is on the Research Team?

Giles Santyr, PhD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with cystic fibrosis or asthma, aged 8 and older, who have never smoked and can hold their breath for at least 16 seconds. Participants must be able to perform consistent pulmonary function tests and not require supplemental oxygen. Those with severe heart conditions, mental incapacitation, recent respiratory infections, claustrophobia that prevents MRI scans, pregnancy or metal implants incompatible with MRI are excluded.

Inclusion Criteria

Participants have no smoking history.

Participants should have a FEV1%pred value greater than 40%.

For participants with CF and asthma, a clinical diagnosis is necessary and they should be at their baseline level of symptom control based on history.

Exclusion Criteria

You have a history of heart problems like heart attacks, irregular heartbeats, or high blood pressure.

Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent/assent from being obtained, or cannot read or understand the written material

You have had a cold or respiratory infection in the past four weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo magnetic resonance imaging using hyperpolarized xenon-129 and inert fluorinated gases to evaluate lung function and structure.

1-2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for changes in lung function and structure after imaging.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lung Clearance Index
• Magnetic Resonance Imaging
• Xenon-129

Trial Overview The study is testing the quality of lung images taken using Xenon-129 and Perfluoropropane (19F) gases in an MRI scan. It aims to compare these images between healthy volunteers and patients with cystic fibrosis or asthma to detect changes in lung structure and function.

How Is the Trial Designed?

Group I: Healthy Active Control 3 Interventions

Healthy Participants ages 8 and older. Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.

Group II: Cystic Fibrisos Active Control 3 Interventions

Participants with cystic fibrosis ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.

Group III: Asthma Active Control 3 Interventions

Participants with asthma ages 8 and older.Participants with inhale hyperpolarized xenon-129 which is used as a contrast agent for lung imaging. Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane). Participants will undergo magnetic resonance imaging and lung clearance index.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

The study demonstrated that injecting hyperpolarized xenon-129 (129Xe) into the bloodstream of rats is a safe method that produces a strong signal in the lungs, allowing for effective imaging of pulmonary perfusion and gas exchange.

This technique revealed important insights, such as ventilation-perfusion deficits and temporary impairments in gas exchange due to saline overload, suggesting its potential as a sensitive and non-invasive tool for evaluating lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary perfusion and xenon gas exchange in rats: MR imaging with intravenous injection of hyperpolarized 129Xe. Driehuys, B., Möller, HE., Cleveland, ZI., et al.[2021]

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 (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]

The recent FDA approval of hyperpolarized 129Xe as an MR contrast agent highlights its growing importance in lung imaging, prompting the need for standardized techniques across research and clinical sites.

The 129Xe MRI Clinical Trials Consortium has established best practices for the entire workflow of 129Xe MRI, including safety monitoring and technical considerations, to ensure effective and safe imaging of lung ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acquiring Hyperpolarized 129Xe Magnetic Resonance Images of Lung Ventilation. Garrison, WJ., Mugler, JP., Mata, JF., et al.[2023]

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]

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]

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]

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]

Citations

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Hyperpolarized 129Xe MRI and Spectroscopy: Quantitative ... Xenon 129 MRI and MR spectroscopy are safe, sensitive, and robust tools for measuring pulmonary ventilation, gas exchange, and microstructure, ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06853145?draw=2&rank=1

Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary ... Functional imaging is a promising tool for assessing treatment response in IPF. Longitudinal decline in forced vital capacity (FVC) and time-to-event outcomes ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11854573/

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

4. publications.ersnet.org publications.ersnet.org/content/erj/53/5/1802188

Hyperpolarised 129 Xe magnetic resonance imaging to ... Of all outcome measures, VDP showed the largest relative improvement (−42.1%, 95% CI −52.1–−31.9%, p<0.0001). These data support further investigation of XeMRI ...

5. 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 ...

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

Safety and Tolerability of Hyperpolarized 129Xe MR ... Although these studies reported no adverse events, they were not specifically designed to assess the safety and tolerability of hyperpolarized 129Xe. Xenon, ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/214375s001lbl.pdf

XENOVIEW (xenon Xe 129 hyperpolarized), for oral inhalation XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02740868

Xenon-129 and Inert Fluorinated Gas Lung Magnetic ... Aim of this study is to evaluate image quality and reproducibility of Xenon-129 and Inert fluorinated (19F) gas Magnetic Resonance Imaging (MRI) and to ...

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

Hyperpolarized Xenon-129 MRI: Narrative Review of ... Hyperpolarized xenon-129 MRI (129XeMRI) has emerged as a powerful tool in the identification, evaluation, and assessment of disease endotyping and in ...