Hyperpolarized 129Xe MRI for Lung Disease

Overseen By Cristal Monge

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Mario Castro, MD, MPH

Disqualifiers: Pregnancy, Cognitive deficits, Institutionalization, others

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

Compensation: Varies

Number of Visits: 1

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how well a special MRI technique using hyperpolarized xenon gas (Hyperpolarized Xe129) can assess lung function. The researchers seek to determine if this method can identify lung issues more precisely. They are looking for healthy volunteers and individuals with diagnosed lung problems who haven't experienced a flare-up in the past month. Participants should be able to hold their breath for about 15 seconds and follow instructions during the MRI. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical advancements.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that hyperpolarized 129Xe MRI is safe for assessing pulmonary function?

Research has shown that inhaling hyperpolarized 129Xe gas is generally safe. In previous studies, both healthy individuals and those with mild to moderate COPD (a lung disease) tolerated it well. Some experienced mild and short-lived side effects, but these were not serious.

The FDA has approved the gas for use in MRI scans, indicating its safety for imaging purposes. Overall, current evidence suggests it is safe for imaging the lungs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hyperpolarized 129Xe MRI for lung disease because it offers a new way to visualize lung function with remarkable clarity. Unlike traditional imaging methods like CT scans or X-rays, which often focus on structural changes, this technique uses hyperpolarized xenon gas to directly assess how well the lungs are working. This innovative approach could lead to earlier and more accurate detection of lung issues, allowing for better-targeted treatments and potentially improving patient outcomes.

What evidence suggests that hyperpolarized 129Xe MRI is effective for assessing lung disease?

Research has shown that hyperpolarized 129Xe MRI, which participants in this trial will receive, effectively detects changes in lung function. Studies have found that this technique can reveal how well different parts of the lung are functioning. In individuals with certain lung diseases, it has effectively identified areas that aren't working properly. This imaging method provides detailed pictures of the lung's tiny structures, aiding doctors in understanding tissue health and airflow. Overall, hyperpolarized 129Xe MRI could serve as a powerful tool for assessing lung health and guiding treatment decisions. ^{2 5 6 7 8}

Who Is on the Research Team?

Peter Niedbalski, PHD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for healthy individuals and those with various lung diseases who can read English or Spanish. Participants must not have had a recent worsening of their condition, be able to hold their breath for about 16 seconds, and have an oxygen saturation above 88%. Pregnant or lactating individuals, those unable to fit into the MRI equipment, or with cognitive issues preventing consent are excluded.

Inclusion Criteria

Subjects with Lung Disease: Ability to read and understand English or Spanish

My lung condition hasn't worsened in the last month.

I do not have any lung diseases.

Exclusion Criteria

Subject is pregnant or lactating

Institutionalization

I cannot hold my breath for 15 seconds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo hyperpolarized 129Xe MRI and anatomical 1H MR imaging to assess pulmonary function

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Xe129

Trial Overview The study is testing hyperpolarized Xenon (Xe129) gas MRI as a method to evaluate lung function in both healthy people and patients with pulmonary conditions. It aims to develop this imaging technique for better assessment of regional lung function.

How Is the Trial Designed?

Group I: Hyperpolarized 129Xe Experimental Treatment 1 Intervention

Administration of hyperpolarized xenon during MRI (up to 1L doses) to develop imaging methods and assess pulmonary function in adults.

Who Is Running the Clinical Trial?

Mario Castro, MD, MPH

Lead Sponsor

Trials

1

Recruited

260+

Published Research Related to This Trial

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]

In a study involving 37 children with asthma and healthy controls, hyperpolarized 129Xe MRI revealed that children with asthma had significantly higher ventilation defect percentages (VDP) and more defects per image slice compared to healthy peers, indicating that this imaging technique can effectively identify lung ventilation issues in pediatric asthma.

The study found that higher VDP and defect counts were associated with increased health care utilization and oral corticosteroid use, suggesting that 129Xe MRI could serve as a valuable biomarker for assessing asthma severity and predicting exacerbation risk in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

129Xe MRI as a measure of clinical disease severity for pediatric asthma. Lin, NY., Roach, DJ., Willmering, MM., et al.[2023]

A portable xenon-129 (129Xe) hyperpolariser was successfully designed and built, allowing for clinically accessible lung MRI without the need for external utilities, making it easy to transport and set up in hospital settings.

The system was tested by transporting it 200 km to a hospital, where it produced high-quality 129Xe MR images within a day of installation, demonstrating its feasibility for multicentre clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone portable xenon-129 hyperpolariser for multicentre clinical magnetic resonance imaging of the lungs. Norquay, G., Collier, GJ., Rodgers, OI., et al.[2023]

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 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]

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]

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 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]

Citations

1. 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 ...

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

Hyperpolarized Xenon-129 MRI: Narrative Review of ... The calculated ratios of xenon-129 in pulmonary microcompartments closely reflect biologically important lung physiology: (1) tissue integrity and alveolar ...

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

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

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. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06853145?draw=2&rank=1

Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary ... Functional imaging is a promising tool for assessing treatment response in IPF. Longitudinal decline in forced vital capacity (FVC) and time-to-event outcomes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3244666/

Safety and Tolerability of Hyperpolarized 129Xe MR ... Inhalation of hyperpolarized 129Xe is well tolerated in healthy subjects and in those with mild or moderate COPD. Subjects do experience mild, transient, 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. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/214375Orig1s000MultidisciplineR.pdf

214375Orig1s000 - accessdata.fda.gov XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) ...