Hyperpolarized Gas MRI for Bronchopulmonary Dysplasia

Overseen By David M Biko, MD

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Xemed LLC

Disqualifiers: Unstable for transport

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

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment MagniXene, hyperpolarized 129Xe MRI, for bronchopulmonary dysplasia?

The research suggests that hyperpolarized 129Xe MRI is a promising technique for evaluating lung function in children without using harmful radiation. It has been used to understand lung diseases like asthma and cystic fibrosis, indicating its potential usefulness in assessing and managing bronchopulmonary dysplasia. ^{1 2 3 4 5}

Is hyperpolarized 129Xe MRI safe for use in humans?

Research indicates that hyperpolarized 129Xe MRI has been studied for safety and tolerability in children, including those with cystic fibrosis, suggesting it is generally safe for human use. ^{1 2 3 5 6}

How is hyperpolarized gas MRI different from other treatments for bronchopulmonary dysplasia?

Hyperpolarized gas MRI is unique because it uses special gases like helium-3 and xenon-129 to create detailed images of the lungs without using harmful radiation. This allows doctors to see how well the lungs are working and to track changes over time, which is especially useful for children with lung conditions like bronchopulmonary dysplasia. ^{1 2 3 7 8}

What is the purpose of this trial?

Hyperpolarized (HP) gas magnetic resonance imaging (MRI) of the lungs offers additional information that cannot be obtained with CT scan, the current gold standard for imaging this disorder. As a nonionizing technique, MRI is an ideal modality for pulmonary imaging; in particular in the infant and pediatric population. Nevertheless, due to the low proton density of the lung parenchyma (only \~20% that of solid tissues), numerous air-tissue interfaces that lead to rapid signal decay, and cardiac and respiratory sources of motion that further degrade image quality , MRI has played a limited role in the evaluation of lung pathologies. In this setting, HP gas (using 129Xe) MRI may play a role in helping determine the regional distribution of alveolar sizes, partial pressure of oxygen, alveolar wall thickness, and gas transport efficiency of the microvasculature within the lungs of infants with a diagnosis of bronchopulmonary dysplasia (BPD).

Research Team

David M Biko, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for infants in the NICU at Children's Hospital of Philadelphia with bronchopulmonary dysplasia (BPD), who are on mechanical ventilation and already receiving sedation. Infants considered unstable for transport to MRI by their primary care team cannot participate.

Inclusion Criteria

I am on a mechanical ventilator through a tube or tracheostomy.

Babies with lung problems who are being cared for at the Children's Hospital of Philadelphia and are part of the Chronic Lung Disease Program.

I am currently receiving sedation as part of my treatment.

Exclusion Criteria

Infants whom the primary care team deems to be unstable for transport to MRI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo hyperpolarized 129-Xenon MR imaging and conventional proton MR imaging of the lung

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

2 years

Treatment Details

Interventions

• MagniXene, hyperpolarized 129Xe MRI

Trial Overview The study tests a new type of lung imaging called hyperpolarized 129Xe MRI, using MagniXene gas. This technique could provide more detailed images of the lungs than current methods, which is especially important for diagnosing and understanding BPD in infants.

Participant Groups

Group I: Hyperpolarized 129Xe MRI for lung diagnosis Experimental Treatment 1 Intervention

All subjects will undergo hyperpolarized 129-Xenon MR imaging (HP MRI) and conventional proton MR imaging of lung.

Who Is Running the Clinical Trial?

Xemed LLC

Lead Sponsor

Trials

8

Recruited

370+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Findings from Research

Magnetic resonance imaging (MRI) using hyperpolarised gases like helium-3 and xenon-129 allows for detailed structural and functional assessments of the lungs without the risks associated with ionising radiation, making it particularly suitable for pediatric patients.

This imaging technique is crucial for understanding and treating chronic lung diseases such as asthma and cystic fibrosis, which are common in children and currently have significant unmet therapeutic needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary functional magnetic resonance imaging for paediatric lung disease. Kirby, M., Coxson, HO., Parraga, G.[2013]

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 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]

Hyperpolarized 129 Xe MRI has shown promise in assessing lung function in neonates with bronchopulmonary dysplasia (BPD), demonstrating good image quality and sensitivity to detect mild ventilation abnormalities in a small study of 9 patients.

The study found elevated apparent diffusion coefficients (ADCs) in BPD patients compared to healthy individuals, indicating potential lung microstructural changes, and a low red blood cell to tissue membrane signal ratio, suggesting altered gas exchange in these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial feasibility and challenges of hyperpolarized 129 Xe MRI in neonates with bronchopulmonary dysplasia. Stewart, NJ., Higano, NS., Mukthapuram, S., 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 (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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pulmonary functional magnetic resonance imaging for paediatric lung disease. [2013]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Hyperpolarized gas MRI in pulmonology. [2020]

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

Hyperpolarized Gas Magnetic Resonance Lung Imaging in Children and Young Adults. [2020]

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

Initial feasibility and challenges of hyperpolarized 129 Xe MRI in neonates with bronchopulmonary dysplasia. [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

Applications of hyperpolarized helium-3 gas magnetic resonance imaging in pediatric lung disease. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

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