Hyperpolarized Xenon MRI for Chronic Obstructive Pulmonary Disease

Overseen By Jane Park

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Xemed LLC

Disqualifiers: Pregnancy, Metal implants, Organ failure, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special type of MRI, using hyperpolarized xenon gas, can enhance understanding of lung function in people with Chronic Obstructive Pulmonary Disease (COPD) undergoing treatment with endobronchial valves. These tiny devices are placed in the lungs to improve breathing. The researchers aim to assess the valves' effectiveness by comparing lung images before and after treatment. The trial seeks COPD patients already scheduled for endobronchial valve therapy who are willing to participate in follow-up visits and tests. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking insights.

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 study team or your doctor.

What prior data suggests that hyperpolarized xenon MRI is safe for assessing lung function in COPD patients?

Research has shown that hyperpolarized xenon-129 MRI for lung imaging is generally safe and well-tolerated. Studies involving both healthy individuals and those with Chronic Obstructive Pulmonary Disease (COPD) reported no serious side effects. This imaging method allows doctors to assess lung function by using xenon-129, a special gas that is safe to inhale.

Although researchers continue to study hyperpolarized xenon-129 MRI, current evidence suggests it is safe for participants. This conclusion is based on past research where participants did not experience significant side effects from the imaging process. Prospective participants can feel confident about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MagniXene Hyperpolarized Xenon MRI because it offers a new way to assess lung function in COPD patients, especially those treated with endobronchial valves. Unlike other imaging techniques, this method uses hyperpolarized xenon gas, which provides clearer and more detailed images of the lungs. This allows doctors to see how well the lungs are functioning both before and after treatment, potentially leading to more personalized and effective care for patients with COPD.

What evidence suggests that hyperpolarized xenon MRI is effective for assessing lung function in COPD patients?

Research shows that hyperpolarized xenon-129 MRI, such as MagniXene, can evaluate lung function in people with chronic obstructive pulmonary disease (COPD). This imaging method reveals how well different parts of the lungs work by showing air replacement during breathing and oxygen levels in the lungs. This understanding clarifies how COPD affects lung tissue and airflow. In this trial, participants will undergo hyperpolarized xenon MRI assessments to monitor changes in lung function after treatments like endobronchial valve therapy, which may improve breathing in COPD patients. ^{2 3 5 6 7}

Who Is on the Research Team?

Kevin Ma, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for COPD patients who are scheduled to receive endobronchial valve therapy. Participants must be alert, cooperative, and willing to return for all scheduled visits and tests.

Inclusion Criteria

Patient is conscious, cooperative and agrees to return for scheduled visits and tests

I have COPD and am scheduled for valve therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo baseline imaging with hyperpolarized xenon-129 MRI prior to receiving endobronchial valve therapy

1-2 hours

1 visit (in-person)

Post-EBV Imaging

Participants undergo follow-up imaging with hyperpolarized xenon-129 MRI approximately 45 days after receiving endobronchial valve therapy

1-2 hours

1 visit (in-person)

Follow-up

Participants are monitored for lung function changes and safety after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• MagniXene Hyperpolarized Xenon MRI

Trial Overview The study is testing the use of a special type of lung imaging called hyperpolarized xenon-129 MRI on COPD patients before and after they get endobronchial valve therapy. This aims to better understand lung function changes due to treatment.

How Is the Trial Designed?

Group I: Hyperpolarized Xenon MRI assessment of lung function in endobronchial valve treated COPD patients Experimental Treatment 1 Intervention

Volunteer patients scheduled for receiving endobronchial valve treatment as part of clinical care will be imaged with hyperpolarized xenon prior and post EBV for assessing lung function and improvement.

Who Is Running the Clinical Trial?

Xemed LLC

Lead Sponsor

Trials

8

Recruited

370+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

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 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]

In a study involving 17 rats, alternating breaths of hyperpolarized helium or xenon with oxygen resulted in less than a 5% decrease in blood oxygen saturation, indicating these protocols are safe for MRI experiments.

However, continuous breathing of noble gases led to significant drops in oxygen saturation, particularly with helium and xenon, highlighting the importance of careful monitoring and standardized procedures during such inhalation protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological response of rats to delivery of helium and xenon: implications for hyperpolarized noble gas imaging. Ramirez, MP., Sigaloff, KC., Kubatina, LV., et al.[2019]

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]

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]

Inhaled hyperpolarized noble gases like He-3 and Xe-129 enhance MRI imaging of the lungs, allowing for better visualization of ventilated airspaces and detection of emphysema-related changes without significant adverse effects, aside from known narcotic effects of Xenon.

This innovative MRI technique shows promise for early detection of obstructive lung diseases and assessing ventilation distribution, providing high spatial and temporal resolution that could improve diagnosis and monitoring of lung conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance tomography with inhalation of polarized noble gases: new perspectives in functional imaging diagnosis of emphysema]. Kauczor, HU., Markstaller, K.[2015]

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 gas MRI is a promising non-invasive imaging technique that can effectively diagnose early lung function deterioration, overcoming challenges faced by traditional proton-based MRI due to short T2* times and low proton density in lung tissue.

This review highlights various applications of hyperpolarized gas MRI, including ventilation imaging and oxygen-pressure mapping, which enhance its diagnostic capabilities compared to other MRI methods and could significantly improve lung disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized gas MRI in pulmonology. Kern, AL., Vogel-Claussen, J.[2020]

In a study involving 32 mice with chronic obstructive pulmonary disease (COPD) induced by cigarette smoke and lipopolysaccharide exposure, significant reductions in pulmonary function were observed after 6 weeks, as measured by hyperpolarized 129 Xe MRI.

Treatment with the anti-inflammatory drug ethyl pyruvate (EP) for 4 weeks improved pulmonary function metrics to levels comparable to healthy controls, suggesting its potential efficacy in COPD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment response of ethyl pyruvate in a mouse model of chronic obstructive pulmonary disease studied by hyperpolarized 129 Xe MRI. Kimura, A., Yamauchi, Y., Hodono, S., et al.[2018]

Hyperpolarized noble gas MRI using helium-3 or xenon-129 enhances MRI signal, making it a promising method for imaging lung function and ventilation.

While there are safety considerations and challenges in clinical application, this technology holds potential for better understanding lung microstructure and function in various pulmonary diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. Liu, Z., Araki, T., Okajima, Y., et al.[2017]

The study demonstrated that fast dynamic hyperpolarised 129Xe ventilation MRI (DXeV-MRI) can non-invasively detect and quantify delayed ventilation in 13 out of 15 COPD patients, highlighting its potential as a diagnostic tool for assessing lung function.

DXeV-MRI provides valuable physiological insights into regional pulmonary function during breathing cycles, which could help guide treatments like lung volume reduction therapy for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed ventilation assessment using fast dynamic hyperpolarised Xenon-129 magnetic resonance imaging. Chen, M., Doganay, O., Matin, T., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05433961

Functional and Structural Assessment of Endobronchial ... This study proposes to use hyperpolarized xenon-129 Magnetic Resonance Imaging (MRI) to study lung function of COPD patients who will receive endobronchial ...

2. withpower.com withpower.com/trial/phase-1-chronic-obstructive-pulmonary-disease-copd-7-2022-fc3ec

Hyperpolarized Xenon MRI for Chronic Obstructive ... This study proposes to use hyperpolarized xenon-129 Magnetic Resonance Imaging (MRI) to study lung function of COPD patients who will receive endobronchial ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40493763/

Advancements and Applications of Hyperpolarized Xenon ... This review provides an overview of the latest developments in hyperpolarized 129Xe MRI technology for COPD assessment in China.

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

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

5. xemed.com xemed.com/products/magnixene/

MagniXene Composition: MagniXene® is Xemed's hyperpolarized xenon-129 magnetic imaging contrast agent. Xenon is a component of air with a 26.4% natural abundance of ...

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. atsjournals.org atsjournals.org/doi/10.1164/rccm.201905-1021OC

Single-Session Bronchial Thermoplasty Guided by 129 Xe ... This study demonstrated that a single BT treatment guided with 129 Xe MRI provides a significant benefit over baseline after 12 weeks.