Xenon MRI for Chronic Lung Disease

Recruiting at 1 trial location

Overseen By Angela P Wilson, RRT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Pregnancy, Claustrophobia, MRI incompatible devices, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop new tools for evaluating lung function using a special type of MRI scan with hyperpolarized Xenon 129. It focuses on individuals with chronic lung diseases such as asthma, COPD, or pulmonary fibrosis. Participants will undergo this MRI and other lung tests to help researchers better understand lung problems. Ideal candidates for this trial are those diagnosed with a chronic lung disease who can hold their breath for 16 seconds. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to improved diagnostic tools for chronic lung diseases.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hyperpolarized Xenon 129 MRI is safe for evaluating chronic lung disease?

Research has shown that inhaling hyperpolarized Xenon 129 is generally safe and well-tolerated. Studies involving both healthy individuals and those with mild or moderate chronic obstructive pulmonary disease (COPD) have demonstrated positive safety outcomes. Participants may experience mild and temporary side effects, but these are not serious.

The FDA has approved the process for preparing Xenon Xe 129, confirming its safety. This approval indicates that the treatment has undergone thorough evaluation for use in medical imaging, offering further reassurance of its safety for individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hyperpolarized Xenon 129 MRI for chronic lung disease because it offers a unique way to visualize lung function in much greater detail than standard imaging techniques like CT scans or traditional MRIs. Unlike other treatments that focus on managing symptoms or slowing disease progression, this method provides a non-invasive way to assess how well the lungs are working over time. It allows for precise tracking of disease progression and could potentially lead to more tailored treatment plans for patients. This approach could revolutionize how doctors monitor and understand chronic lung conditions, leading to improved outcomes.

What evidence suggests that hyperpolarized Xenon 129 MRI is effective for evaluating chronic lung disease?

Research has shown that a special type of MRI using hyperpolarized Xenon 129 (129-Xe) effectively assesses lung diseases. In this trial, participants with chronic lung disease will undergo pulmonary function tests and hyperpolarized Xenon MRI at each visit. This MRI identifies problems with lung gas exchange, crucial for those with lung issues. In some cases, it tracks changes in lung function over time, helping to evaluate treatment effectiveness. It provides a clear picture of the lungs and can detect areas with poor airflow. This tool holds promise for better understanding lung health and could improve lung disease management. ^{3 4 6 7 8}

Who Is on the Research Team?

Grace E Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with lung diseases like asthma, COPD, or pulmonary fibrosis. Participants must be able to understand the study and consent to it, have a certain level of lung function (FEV1 >25% predicted), and be in stable health. They can't join if they're pregnant, have MRI-incompatible devices in their body, severe claustrophobia, oxygen saturation too low, or conditions preventing them from performing required tests.

Inclusion Criteria

Your lung capacity is greater than 25% of what is expected and is more than 0.5 liter.

Subject is judged to be in otherwise stable health on the basis of medical history

I can hold my breath for 16 seconds.

Exclusion Criteria

I am able to understand and consent to my own medical treatment.

I have a metal device or object in my body that cannot be removed.

Patient is pregnant or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo informed consent, medical history, vital signs, full pulmonary function tests, proton MRI, and 129-Xe MRI

1-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after baseline assessment

5 years

Multiple visits over 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Xenon 129

Trial Overview The trial involves using a special type of MRI called hyperpolarized Xenon 129 MRI along with Pulmonary Function testing. These tools will help measure different aspects of lung function such as gas exchange and airway obstruction in people with chronic lung disease.

How Is the Trial Designed?

Group I: MRI at baseline and over time Experimental Treatment 1 Intervention

Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Xenon MRI at each visit.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Published Research Related to This Trial

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]

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 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]

The continuous flow-type hyperpolarizing (CF-HP) system allows for effective lung imaging using hyperpolarized (129)Xe MRI at very low concentrations of xenon, minimizing the anesthetic effects and reducing xenon consumption.

Using a 70% xenon gas mixture resulted in better signal-to-noise ratios for both gas and dissolved-phase images compared to a 3% mixture, although the apparent diffusion coefficient (ADC) was higher with the 3% mixture, indicating a complex relationship between concentration and imaging quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 129 Xe MRI of the mouse lung at a low xenon concentration using a continuous flow-type hyperpolarizing system. Wakayama, T., Kitamoto, M., Ueyama, T., et al.[2015]

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 xenon-129 (Xe129) MRI is a promising imaging technique that can effectively assess lung function and gas uptake in patients with chronic obstructive pulmonary disease (COPD), showing strong correlations with other imaging modalities like CT and gadolinium-enhanced MRI.

In this pilot study involving four COPD patients and four healthy subjects, four distinct patterns of functional abnormalities were identified in COPD patients, highlighting the heterogeneous nature of the disease and the potential of Xe129 MRI to reveal unique physiological changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probing Changes in Lung Physiology in COPD Using CT, Perfusion MRI, and Hyperpolarized Xenon-129 MRI. Qing, K., Tustison, NJ., Mugler, JP., et al.[2020]

Citations

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

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary ... The quantification of dissolved 129Xe can provide data on gas-exchange derangements in lung disease. In animal studies, lung fibrosis results in ...

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

Hyperpolarized Xenon-129 MRI: Narrative Review of ... This indicates that three-dimensional single-breath chemical shift imaging 129XeMRI can effectively characterize lung diseases, monitor treatment responses, and ...

3. pubs.rsna.org pubs.rsna.org/doi/10.1148/ryct.240562

Hyperpolarized 129Xe MRI and Spectroscopy: Quantitative ... Efforts for standardization of analyses are ongoing, spearheaded by the 129Xe MRI Clinical Trials Consortium (https://www.129Xectc.org/), which ...

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

Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary ... The study group employed hyperpolarized xenon-129 magnetic resonance imaging (Xe129-MRI) to quantify and localize deficits in pulmonary ventilation and ...

5. mearis.cms.gov mearis.cms.gov/public/publications/ntap/NTP221017PBF9L

MEARIS™ | Publication | ntap | NTP221017PBF9L - CMS For patients with lung disease that may be prescribed an HP Xe 129 MRI the resulting MS-DRGs are determined by the patient's diagnosis codes, not the XENOVIEW ...

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

Safety and Tolerability of Hyperpolarized 129Xe MR ... Inhalation of hyperpolarized 129Xe is well tolerated in healthy subjects and in those with mild or moderate COPD. Subjects do experience mild, transient, xenon- ...

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

XENOVIEW (xenon Xe 129 hyperpolarized), for oral inhalation The mean XENOVIEW dose used in these trials was 99 mL DE of hyperpolarized xenon Xe 129 at the time of measurement within 5 minutes of administration. Study 1.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03002389

Hyperpolarized Xenon-129 MRI: a New Multi-dimensional ... Hyper polarized xenon-129 MRI (HXe MRI) is a unique imaging test which can detect how air is flowing in and out of lungs and how oxygen can move from ...