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

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal population of children and adults and in adults and also in children with respiratory compromise due to a variety of diseases.

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 data supports the effectiveness of the treatment Hyperpolarized 129 Xenon MRI for respiratory disorders?

Research shows that Hyperpolarized 129 Xenon MRI is promising for assessing lung function, as it can evaluate both ventilation (airflow) and gas transfer in the lungs. It has been used to study lung diseases and may help identify ventilation issues in conditions like pulmonary embolism and chronic obstructive airway diseases. ^{1 2 3 4 5}

Is Hyperpolarized Xenon MRI safe for humans?

Research on Hyperpolarized Xenon MRI, which uses a special type of gas for lung imaging, suggests it is generally safe for humans. It has been used in clinical trials and studies for various lung conditions, and while it is still mainly available in research settings, no major safety concerns have been reported. ^{1 2 5 6 7}

How does hyperpolarized xenon MRI differ from other treatments for respiratory disorders?

Hyperpolarized xenon MRI is unique because it uses a special form of xenon gas to create detailed images of the lungs, allowing doctors to see both how air moves through the lungs and how well gases are exchanged. This imaging technique is different from other treatments because it provides a non-invasive way to assess lung function and structure, which can help in diagnosing and managing respiratory disorders. ^{1 3 4 5 8}

Research Team

Jason C. Woods, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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 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]

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 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 (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 (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]

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]

References

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

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. [2017]

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

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. [2019]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Small animal imaging with hyperpolarized 129Xe magnetic resonance. [2019]

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

Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. [2020]

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

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