Hyperpolarized Xenon MRI for Respiratory Disorders

(HPXeMR Trial)

Overseen By Jason C. Woods, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Must not be taking: Rescue inhalers

Disqualifiers: Heart defect, Pregnancy, Asthma, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for assessing lung function using hyperpolarized xenon during an MRI scan. The goal is to determine if Hyperpolarized Xenon-129 MRI can provide better lung images for individuals with various breathing issues. Participants must be able to hold their breath for up to 16 seconds and should not have a history of uncontrolled asthma or recent respiratory infections. Those interested in understanding their lung function and meeting these criteria may find this trial suitable. As a Phase 1, Phase 2 trial, the research focuses on understanding how the method works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have uncontrolled asthma requiring frequent use of a rescue inhaler, you may not be eligible to participate.

What prior data suggests that hyperpolarized xenon MRI is safe for respiratory assessment?

Research has shown that hyperpolarized 129Xe MRI, which uses a special type of xenon gas to create detailed lung images, has been studied mainly for its ability to produce clear images. Although earlier studies did not focus on safety, they found no negative side effects from using this gas for imaging. Specifically, no harmful effects were reported in those tests.

These studies primarily assessed the effectiveness of this imaging method, not its safety. However, the absence of reported side effects is encouraging. Since this trial is in the early stages, researchers are closely monitoring the treatment for safety. Prospective participants should know that the treatment is being carefully studied to ensure its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional imaging techniques for respiratory disorders, which typically rely on proton MRI, the Hyperpolarized 129 Xenon MRI offers a fresh approach. This method uses hyperpolarized xenon gas, which is inhaled by the patient, allowing for clearer and more detailed images of lung function. Researchers are excited about this technique because it provides a non-invasive way to assess lung health and function with potentially greater precision than current methods. This innovation could lead to earlier and more accurate diagnosis and monitoring of respiratory conditions, offering a promising tool for both children and adults.

What evidence suggests that hyperpolarized xenon MRI is effective for assessing lung function in respiratory disorders?

Research shows that hyperpolarized 129Xe (xenon) MRI, which participants in this trial will receive, is a promising method for assessing lung function. Studies have found that it captures detailed images of the lungs, allowing doctors to observe how different lung regions function. This technique effectively detects changes in lung function in individuals with lung diseases like UIP. It employs a special type of xenon gas to produce clear lung images without requiring surgery or other invasive procedures. This approach could help track treatment effectiveness for lung conditions, offering a new way to understand and monitor lung health. ^{3 4 6 7 8}

Who Is on the Research Team?

Jason C. Woods, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for children and adults aged 6 or older who can hold their breath for up to 16 seconds. It's not suitable for pregnant individuals, those with recent respiratory infections, low oxygen levels without support, metal implants that interfere with MRI, heart defects, uncontrolled asthma, or claustrophobia.

Inclusion Criteria

Participant must be able to hold breath for up to 16 seconds

I am 6 years old or older.

Exclusion Criteria

Participant is claustrophobic and unable to tolerate the imaging

Standard MRI exclusions (metal, implants)

Pregnancy or positive pregnancy test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Session

Participants undergo MRI scans using hyperpolarized 129Xe gas to assess lung function

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

2 follow-up calls

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 129 Xenon

Trial Overview The study tests the use of Hyperpolarized 129 Xenon gas during an MRI scan to assess lung function in healthy people as well as those with compromised lungs due to various diseases.

How Is the Trial Designed?

Group I: Hyperpolarized 129 Xenon Experimental Treatment 1 Intervention

Administration of up to 1 liter doses of Hyperpolarized Xenon gas during MRI (less for children) to optimize acquisition of images for children and adults vs. proton MR imaging

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

Hyperpolarized (HP) noble gases like (3)He and (129)Xe are emerging as noninvasive contrast agents for MRI, particularly useful in diagnosing pulmonary diseases.

Recent advancements in HP (129)Xe MR measurements have enhanced our ability to study lung dysfunctions in mice, paving the way for potential applications in human diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small animal imaging with hyperpolarized 129Xe magnetic resonance. Imai, H., Kimura, A., Fujiwara, H.[2019]

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 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]

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]

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 is a new imaging technique that allows for detailed lung imaging and can also detect 129Xe in the brain, providing insights into brain parenchyma and blood vessels.

The study outlines specific protocols for using 129Xe MRI in both rodents and humans, highlighting its potential for advanced medical imaging applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. Chahal, S., Prete, BRJ., Wade, A., et al.[2019]

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]

Citations

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

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

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

Hyperpolarized 129Xe MRI and Spectroscopy: Quantitative ... Hyperpolarized xenon 129 (129Xe) MRI uses inhaled 129Xe gas to visualize pulmonary function and microstructure.

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1090780723000228

Hyperpolarized 129Xe MRI at low field: Current status and ... Hyperpolarized 129Xe MRI permits high-sensitivity in-vivo imaging of human lungs. · Improved SNR and longer T2* at low field suggests optimum field strength ...

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 ... Although these studies reported no adverse events, they were not specifically designed to assess the safety and tolerability of hyperpolarized 129Xe. Xenon, ...

7. 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 ...

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

Hyperpolarized Xenon-129 MRI: Narrative Review of ... Hyperpolarized xenon-129 MRI (129XeMRI) has emerged as a powerful tool in the identification, evaluation, and assessment of disease endotyping and in ...