Hyperpolarized 129Xe MRI for Lung Disease

Overseen By Cristal Monge

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Mario Castro, MD, MPH

Disqualifiers: Pregnancy, Cognitive deficits, Institutionalization, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to develop and evaluate the usefulness of hyperpolarized (HP) 129Xe gas MRI for regional assessment of pulmonary function.

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 data supports the effectiveness of the treatment Hyperpolarized Xe129 for lung disease?

Research shows that Hyperpolarized 129Xe MRI is effective in assessing lung function by evaluating ventilation and gas transfer, which are crucial for managing lung diseases. This imaging technique has been standardized and approved by the FDA, indicating its reliability and growing use in clinical settings. ^{1 2 3 4 5}

Is Hyperpolarized 129Xe MRI safe for humans?

Research shows that Hyperpolarized 129Xe MRI is generally safe and well-tolerated in both healthy volunteers and patients with lung diseases like cystic fibrosis and chronic obstructive pulmonary disease. Studies have evaluated the safety of inhaling the gas and holding the breath for short periods, and no significant safety concerns have been reported. ^{1 2 5 6 7}

How is hyperpolarized 129Xe MRI different from other treatments for lung disease?

Hyperpolarized 129Xe MRI is unique because it provides detailed images of lung function by assessing both ventilation (airflow) and gas transfer, which is not typically possible with standard imaging techniques. This method uses a special form of xenon gas that enhances MRI signals, allowing for better visualization of lung structures and function, potentially improving the management of lung diseases. ^{1 4 6 8 9}

Research Team

Peter Niedbalski, PHD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Hyperpolarized Xe129 (Gas)

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.

Participant Groups

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+

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]

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 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]

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]

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 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]

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

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

3. 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]

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

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Standalone portable xenon-129 hyperpolariser for multicentre clinical magnetic resonance imaging of the lungs. [2023]

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

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. [2019]

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

129Xe MRI as a measure of clinical disease severity for pediatric asthma. [2023]