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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method for obtaining clear lung images using hyperpolarized gas MRI, potentially more effective than standard CT scans. It targets infants with bronchopulmonary dysplasia (BPD), a lung condition affecting breathing. The goal is to determine if this MRI method, specifically using MagniXene (hyperpolarized 129Xe MRI), can provide better information about lung function in these infants. Infants in the NICU with BPD who are already sedated and require breathing assistance might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how this new imaging method works in people, offering participants the chance to be among the first to benefit from this innovative approach.

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 prior data suggests that hyperpolarized 129Xe MRI is safe for lung diagnosis in infants with bronchopulmonary dysplasia?

Research has shown that the type of MRI used in MagniXene, called hyperpolarized 129Xe MRI, has been safe and well-tolerated in past studies. This imaging technique provides clear pictures and can detect even mild breathing problems in patients with bronchopulmonary dysplasia (BPD). Studies have found no major safety issues with this MRI, especially for lung conditions like chronic obstructive pulmonary disease (COPD) and asthma.

This MRI does not use ionizing radiation, making it generally safer for the lungs and particularly suitable for children and infants. While potential risks should always be considered, current evidence suggests that this imaging method is safe and well-tolerated in the groups studied so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized 129Xe MRI for bronchopulmonary dysplasia (BPD) because it offers a new way to visualize lung function in real-time. Unlike traditional imaging methods that focus on structural changes, this technique uses hyperpolarized xenon gas to capture detailed images of how air moves through the lungs. This innovative approach could lead to more accurate diagnoses and better management of BPD, giving healthcare providers a powerful tool to tailor treatments to each patient's unique needs.

What evidence suggests that hyperpolarized 129Xe MRI is effective for bronchopulmonary dysplasia?

Research shows that hyperpolarized 129Xe MRI, which participants in this trial will undergo, can effectively identify breathing problems in individuals with bronchopulmonary dysplasia (BPD). Studies have demonstrated that this imaging method provides clear pictures and is sensitive enough to detect even minor lung ventilation issues. It reveals how air and oxygen move through the lungs and can uncover structural problems that other scans might miss. This type of MRI has been successfully used for other lung conditions like asthma and COPD (chronic obstructive pulmonary disease), highlighting its potential in evaluating lung function. Hyperpolarized 129Xe MRI is especially promising because it captures detailed images of the lungs without the risks associated with traditional CT scans. ^{1 2 4 6 7}

Who Is on the Research Team?

David M Biko, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10629838/

Initial Feasibility and Challenges of Hyperpolarized 129Xe ...

129 Xe ventilation imaging showed good image quality and sufficient sensitivity to detect mild ventilation abnormalities in patients with BPD.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04035629

NCT04035629 | 129Xe MRI in Pediatric Population With BPD

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 ...

3.

mdpi.com

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

Hyperpolarized Xenon-129 MRI: Narrative Review of ...

Publications using 129XeMRI to assess clinical observations or outcomes in pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39434582/

Quantifying Spatial Distribution of Ventilation Defects in ...

Hyperpolarized 129 Xe MRI assesses lung ventilation, often using the ventilation defect percentage (VDP). Unlike VDP, defect distribution index (DDI) ...

5.

atsjournals.org

atsjournals.org/doi/full/10.1164/rccm.202203-0606OC

Image Phenotyping of Preterm-Born Children Using ...

129 Xe MRI can be used to assess and phenotype functional and microstructural abnormalities in the lungs of preterm-born children.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9952860/

Image Phenotyping of Preterm-Born Children Using ...

Hyperpolarized helium-3 (3He) or xenon-129 (129Xe) MRI provides three-dimensional (3D) in vivo measurements of lung ventilation and microstructure through ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03455686

Exploring the Utility of Hyperpolarized 129Xe MRI in ...

This is a single centre exploratory study that aims to apply hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) methods and measurements in ...