129Xe MRI in Pediatric Population With BPD

NCT04035629 | Withdrawn Phase 1 FDA Drug FDA Device

• 1 other identifier: 17-014532
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bronchopulmonary Dysplasia

Keywords

BPD

Outcome Measures

Primary Outcomes (4)

• Analyze 129Xe MRI ventilation maps for regions of abnormal ventilation.

  129Xe MRI can reveal unventilated regions of the lungs where the gas cannot reach after being inhaled due to restrictions of the airways.

  2 years

• Analyze 129Xe MRI ADC maps and check for regions of deviations from literature reported normal values.

  Apparent diffusion coefficient (ADC) maps are extracted 129Xe MRI from a single breath-hold pulse sequence. Reference values for healthy lungs are available in literature.

  2 years

• Analyze oxygen partial pressure (PAO2) maps extracted from 129Xe MRI

  Oxygen partial pressure (PAO2) maps can be extracted from 129Xe MRI maps in a single breath-hold. Regions of the lungs that show abnormal PAO2 values are susceptible of improper ventilation or gas exchange.

  2 years

• Analyze gas exchange and transport coefficient maps and global values as extracted from 129Xe MRI.

  Xenon is soluble in lung tissue and blood and can be used for characterizing gas exchange properties at the alveolar level.

  2 years

Secondary Outcomes (3)

• Compare 129Xe biometrics to structural magnetic resonance imaging of the lung and clinically available CT and CT angiograms.

  2 years

• Correlate 129Xe MRI derived ventilation/perfusion (V/Q) measures to a standard clinically used measure of V/Q.

  2 years

• Correlate 129Xe biometrics to right and left pulmonary arterial flow.

  2 years

Study Arms (1)

Hyperpolarized 129Xe MRI for lung diagnosis

EXPERIMENTAL

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

Combination Product: MagniXene, hyperpolarized 129Xe MRI

Interventions

MagniXene, hyperpolarized 129Xe MRI COMBINATION_PRODUCT

All subjects will undergo hyperpolarized 129-Xenon MR imaging (HP MRI) and conventional proton MR imaging of lung. Hyperpolarized 129Xe gas is prepared in a process termed spin-exchange optical pumping. Xenon is highly lipophilic and therefore soluble in blood and tissue, making it an excellent tool for imaging the gas in both the air spaces (gas-phase imaging) and dissolved in the lung parenchyma (dissolved-phase imaging). This solubility in combination with xenon's chemical shift properties, results in the possibility of quantifying pulmonary gas exchange and gas transport within the parenchyma. Additionally, previous images and lung function tests will be reviewed to compare findings and evaluate if there is a correlation between the obtained results.

Hyperpolarized 129Xe MRI for lung diagnosis

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants admitted to the NICU at the Children's Hospital of Philadelphia with bronchopulmonary dysplasia who are followed by the Chronic Lung Disease Program.
• Subjects mechanically ventilated either via and endotracheal tube or via a tracheostomy.
• Subjects already receiving sedation as part of clinical care.

You may not qualify if:

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

Sponsors & Collaborators

• Xemed LLC: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David M Biko, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: July 29, 2019
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)