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

Trial Summary

What is the purpose of this trial?

Subjects aged 18-85 with lung disease will undergo hyperpolarized Xenon 129 (129-Xe) MRI and Pulmonary Function testing for the development of tools to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect percent (VDP) and pulmonary gas exchange measurements obtained by analysis of hyperpolarized 129-Xe MRI.

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 data supports the effectiveness of the treatment Hyperpolarized Xenon 129 for chronic lung disease?

Research shows that Hyperpolarized Xenon 129 MRI is effective in assessing lung functions like ventilation and gas transfer, which are crucial for managing chronic lung diseases such as COPD (chronic obstructive pulmonary disease). This imaging technique provides detailed insights into lung physiology, making it a promising tool for evaluating and managing lung conditions. ^{1 2 3 4 5}

How is Xenon MRI different from other treatments for chronic lung disease?

Xenon MRI is unique because it uses hyperpolarized xenon gas to provide detailed images of lung function, specifically assessing both ventilation and gas transfer, which is not possible with standard imaging techniques. This method offers a non-invasive way to evaluate lung physiology and can help in managing chronic lung diseases by identifying ventilation-perfusion mismatches and tracking treatment success. ^{1 4 5 6 7}

Research Team

Grace E Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Eligibility Criteria

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

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

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

I am between 18-85 years old with a diagnosed lung condition.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [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. United States pubmed.ncbi.nlm.nih.gov

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

4. United States 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. [2015]

5. Ireland pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. [2019]

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

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