Hyperpolarized Gas MRI for Bronchopulmonary Dysplasia

Overseen By David M Biko, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Xemed LLC

No Placebo Group

Trial Summary

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

Treatment Details

Interventions

• MagniXene, hyperpolarized 129Xe MRI (Gas)

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+