Hyperpolarized Xenon MRI for Lung Function Assessment in Healthy Subjects

Recruiting at 1 trial location

Overseen By Angela P Wilson, RRT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Pregnancy, Oxygen saturation <90%, 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: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve tools for assessing lung function using a special MRI technique called hyperpolarized Xenon MRI. It focuses on understanding the quality and consistency of lung images in individuals without lung issues. The trial seeks healthy volunteers who can hold their breath for up to 16 seconds, have a BMI between 18 and 40, and a minimal smoking history of less than one pack per year. Participants will undergo this special MRI and other lung function tests. This opportunity allows those in stable health to contribute to advancing lung health research. As an unphased trial, it offers a unique chance to contribute to foundational research that could enhance future diagnostic techniques.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves healthy volunteers, it is likely that participants are not on significant medications.

What prior data suggests that hyperpolarized Xenon MRI is safe for lung function assessment?

Research has shown that hyperpolarized Xenon MRI is generally safe for people. In a study with healthy volunteers and patients with chronic obstructive pulmonary disease, the procedure did not cause any major side effects. Most individuals undergo the imaging process without issues.

This method uses a special type of xenon gas to capture detailed images of the lungs. It is non-invasive, meaning it doesn't involve surgery or entering the body, making it safe for most individuals.

Several studies have tested this technique, further supporting its safety. While some may feel a bit uncomfortable in the MRI machine, such as feeling enclosed, the use of hyperpolarized xenon gas has not shown any harmful effects in the studies reviewed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized xenon MRI because it offers a non-invasive way to assess lung function with incredible precision. Unlike traditional methods like spirometry or CT scans, which provide limited detail or involve radiation exposure, this technique uses hyperpolarized xenon gas to create detailed images of how air moves and is absorbed in the lungs. This breakthrough could lead to earlier and more accurate detection of lung issues, providing a clearer picture of lung health without discomfort or risk.

What evidence suggests that hyperpolarized Xenon MRI is effective for lung function assessment?

Research shows that hyperpolarized Xenon MRI, which participants in this trial will undergo, effectively assesses lung function. Studies have found that it provides a clear picture of lung function and excels at detecting changes, especially in conditions like cystic fibrosis and other lung diseases. This MRI method offers a detailed view of the lungs without requiring surgery or other invasive procedures. It also resembles tests like Xenon-133 scintigraphy, offering comparable insights into lung health. ^{4 5 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 healthy adults aged 18-85 who can hold their breath up to 16 seconds, have a BMI of 18-40, and a minimal smoking history. They must be in stable health and able to perform certain lung function tests. People with mental incapacitation, severe claustrophobia, implanted devices or metal in their body that cannot be removed are excluded.

Inclusion Criteria

I can hold my breath for up to 16 seconds.

BMI between 18 and 40

Stable health on the basis of medical history

Exclusion Criteria

Patient is pregnant

I am able to understand and consent to the study on my own.

My oxygen levels drop below 90% when I'm lying down without extra oxygen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Imaging and Testing

Participants undergo hyperpolarized 129-Xe MRI and full pulmonary function tests

1-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Xenon MRI

Trial Overview The study is testing the use of hyperpolarized Xenon MRI technology on healthy subjects. It aims to develop tools for assessing image quality and consistency across repeated scans while also evaluating participants' lung function.

How Is the Trial Designed?

Group I: Healthy Volunteers Experimental Treatment 1 Intervention

Healthy volunteers 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+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Published Research Related to This Trial

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]

Inhalation of hyperpolarized xenon-129 (129Xe) was found to be safe and well tolerated among 44 subjects, including healthy individuals and patients with chronic obstructive pulmonary disease (COPD), with no serious adverse events reported.

While 91% of participants experienced mild and transient symptoms such as dizziness and euphoria, these symptoms resolved quickly without the need for clinical intervention, indicating that the procedure is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. Driehuys, B., Martinez-Jimenez, S., Cleveland, ZI., et al.[2022]

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]

Hyperpolarized 129Xe gas is safe and well-tolerated as an inhaled contrast agent for MRI in children, with no serious adverse events reported during the study involving 28 participants aged 6 to 16 years.

While some children experienced mild and temporary changes in oxygen saturation and heart rate after inhalation, these effects were consistent with expected physiological responses and resolved quickly, indicating that 129Xe MRI is feasible for assessing lung function in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. Walkup, LL., Thomen, RP., Akinyi, TG., et al.[2022]

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]

High-quality MRI of lung ventilation can be achieved using naturally abundant xenon (NAXe) gas, demonstrating its potential as a cost-effective imaging agent for pulmonary studies.

The study showed that NAXe MRI provided comparable image quality to enriched xenon and helium-3 (3He) imaging, with the ability to detect minor ventilation defects, particularly in a healthy smoker's lungs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of human lung ventilation imaging using highly polarized naturally abundant xenon and optimized three-dimensional steady-state free precession. Stewart, NJ., Norquay, G., Griffiths, PD., et al.[2022]

Hyperpolarized 129 Xe MRI provides comparable quantitative metrics of lung ventilation and microstructure to traditional 3 He MRI, showing a strong correlation in ventilated volume percentages (VV%) and mean apparent diffusion coefficients (ADC) at 1.5T.

The study demonstrated good repeatability for both 3 He and 129 Xe ADC values, indicating that hyperpolarized 129 Xe MRI can be a reliable method for assessing lung function in patients, including those with chronic obstructive pulmonary disease (COPD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 3 He and 129 Xe MRI for evaluation of lung microstructure and ventilation at 1.5T. Stewart, NJ., Chan, HF., Hughes, PJC., et al.[2022]

Hyperpolarized (HP) 129 Xe MRI is a safe and rapid imaging technique that provides unique insights into lung function, including ventilation and gas exchange, which are not achievable with traditional imaging methods.

To enhance the consistency and reliability of HP 129 Xe MRI across different research sites, the 129 Xe MRI Clinical Trials Consortium has proposed standardized protocols for image acquisition and dosing, aiming to facilitate its broader use in clinical trials for pulmonary disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocols for multi-site trials using hyperpolarized 129 Xe MRI for imaging of ventilation, alveolar-airspace size, and gas exchange: A position paper from the 129 Xe MRI clinical trials consortium. Niedbalski, PJ., Hall, CS., Castro, M., 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]

Citations

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

Hyperpolarized Xenon-129 MRI: Narrative Review of Clinical ... Several investigators have evaluated the effectiveness of 129XeMRI in assessing lung function in patients with CF. Not surprisingly, 129XeMRI is reliable in ...

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03417687?term=XENON%20(133%20XE)&rank=3

Hyperpolarized Xenon MRI for Assessment of Pulmonary ... This study compares the equivalence of hyperpolarized 129Xe MRI as compared to 133Xe scintigraphy for the evaluation of pulmonary function in patients being ...

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

MEARIS™ | Publication | ntap | NTP221017PBF9L - CMS XENOVIEW is the first and only HP lung MRI diagnostic drug that rapidly and directly enables MR images to quantify regional lung function while not ...

5. pulmonologyadvisor.com pulmonologyadvisor.com/features/129xe-mri-offers-detailed-view-of-pulmonary-function-and-huge-clinical-potential/

129Xe MRI Offers Detailed View of Pulmonary Function ... Hyperpolarized 129xenon gas MRI (129Xe MRI), a noninvasive technology offering a highly detailed view of lung function, holds great clinical ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03418090

Study Details | NCT03418090 | Hyperpolarized Xenon MRI ... This study compares the equivalence of hyperpolarized 129Xe MRI to 133Xe scintigraphy for the evaluation of pulmonary function in patients being evaluated for ...

8. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.220069

Lung Abnormalities Detected with Hyperpolarized 129 Xe ... Hyperpolarized xenon 129 MRI and total lung diffusion capacity for carbon monoxide demonstrate significantly impaired gas transfer in nonhospitalized ...