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

Trial Summary

What is the purpose of this trial?

Healthy volunteers aged 18-85 will undergo hyperpolarized 129-Xe MRI and pulmonary function testing for the development of tools to assess image signal to noise and reproducibility of spin-density and diffusion-weighted imaging.

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 data supports the effectiveness of the treatment Hyperpolarized Xenon MRI for lung function assessment?

Research shows that Hyperpolarized Xenon MRI is effective in assessing lung function by providing detailed images of lung ventilation and gas uptake, which is useful in conditions like COPD (a lung disease that makes it hard to breathe). This imaging technique offers unique insights into lung physiology that other methods may not provide. ^{1 2 3 4 5}

Is Hyperpolarized Xenon MRI safe for humans?

Research shows that Hyperpolarized Xenon MRI is generally safe and well-tolerated in both healthy volunteers and patients with conditions like cystic fibrosis and chronic obstructive pulmonary disease. Studies have evaluated the safety of inhaling hyperpolarized xenon gas, and best practices for monitoring safety during these studies have been established. ^{1 6 7 8 9}

How is hyperpolarized xenon MRI different from other lung function assessments?

Hyperpolarized xenon MRI is unique because it uses a special form of xenon gas to create detailed images of lung function, allowing for both global and regional assessment of lung ventilation and gas exchange. This method provides 3-dimensional imaging and can reveal detailed information about lung physiology that other imaging techniques may not capture. ^{1 3 4 5 10}

Research Team

Grace E Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 (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]

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]

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 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]

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]

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 (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]

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]

References

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

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

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

Probing Changes in Lung Physiology in COPD Using CT, Perfusion MRI, and Hyperpolarized Xenon-129 MRI. [2020]

3. Ireland pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2022]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. [2022]

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

Acquiring Hyperpolarized 129Xe Magnetic Resonance Images of Lung Ventilation. [2023]

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

Chronic obstructive pulmonary disease: safety and tolerability of hyperpolarized 129Xe MR imaging in healthy volunteers and patients. [2022]

9. United States 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. [2022]

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

Comparison of 3 He and 129 Xe MRI for evaluation of lung microstructure and ventilation at 1.5T. [2022]