129Xe MRI in Pediatric Population With BPD

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Brief Title

129Xe MRI in Pediatric Population With BPD

Official Title

A Prospective Study of Hyperpolarized 129 Xe MRI in in a Pediatric Population With Bronchopulmonary Dysplasia

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).
    

Detailed Description

      The most common respiratory complication of preterm birth, bronchopulmonary dysplasia (BPD),
      defined by a clinically assessed need for supplemental oxygen support at 36 weeks
      post-menstrual age, has actually increased in incidence as advancements in clinical
      respiratory care have improved initial survivability for very premature neonates. However,
      the burden of pulmonary disease continues beyond the NICU; the survivors are at greater risk
      for respiratory-related rehospitalization and diminished pulmonary capacity. Pulmonary
      imaging of the neonate has been limited to the clinical assessment of acute changes in
      respiratory status. The most widely accessible clinical imaging modalities, radiograph and
      computed tomography (CT), have significant limitations. Chest radiograph's sensitivity in the
      acute setting is limited because patients with significant respiratory dysfunction may
      exhibit only minor radiographic abnormalities, and although CT is considered the gold
      standard for clinical pulmonary imaging, it is not widely implemented because neonates may
      require sedation, especially for high-resolution CT, and are especially vulnerable to damage
      from ionizing radiation. Furthermore, CT is not appropriate for longitudinal assessment
      because of the link between serial radiation exposure and increased cancer risk.

      As a nonionizing technique, magnetic resonance imaging (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. Pulmonary MRI of the neonate is additionally confounded by small patient
      size and the delicate nature of transporting a NICU patient to the scanner. To overcome these
      limitations, the use of inhaled, hyperpolarized (HP) noble gases such as helium-3 (3He) and
      xenon-129 (129Xe) has come into play. Filling the air spaces within the lungs with either of
      these HP gases provides enough signal and contrast to obtain quality images on MRI.

      There has been extensive work with HP 3He MRI in both the adult and pediatric population, but
      this gas is in extremely limited supply, making it increasingly expensive. 129Xe, on the
      other hand, is part of the atmosphere and as such does not suffer from supply constraints.
      Also, xenon dissolves in the lung tissue and blood, a process that is associated with
      characteristic shifts in the resonance frequency of 129Xe. As a result, the uptake and
      subsequent transport of 129Xe gas by the pulmonary circulation can be monitored, quantified
      and analyzed with regard to lung function at a temporal and spatial resolution that is
      infeasible with any other existing non-invasive modality.

      In this study, the lung function in up to 30 infant subjects will be evaluated using HP 129Xe
      MRI. The subjects will be intubated and sedated neonates with known diagnosis of BPD.
      Although these subjects have lung disease and may be chronically intubated, they are stable
      clinically and not acutely ill decreasing the overall risk. When inhaled, 129Xe can be imaged
      within the lung parenchyma. Using a set of specialized MRI pulse sequences, the diffusion and
      gas-exchange properties of 129Xe in the lungs of these subjects will be evaluated. This will
      enable the investigators to determine the regional distribution of alveolar sizes, partial
      pressure of oxygen, alveolar wall thickness, and gas transport efficiency of the
      microvasculature within the lung. Each participant will be imaged once using HP 129Xe MRI
      along with the additional routine proton MRI sequences to further evaluate the structure,
      volume, and perfusion of the lung parenchyma.

      The overall goal of this study is to develop improved quantitative imaging-based lung
      function parameters to evaluate BPD and determine the phenotypical variants of BPD using HP
      MRI. HP gas MRI offers additional information that cannot be obtained with CT, the current
      gold standard for imaging this disorder. Further, MRI offers the advantage of non-ionizing
      radiation, which is all the more important in the pediatric population particularly within
      this population who may getting repeat CT examinations throughout their lifetime. Although
      older children and adults may also benefit from this technology, the improved imaging and
      phenotyping of BPD will hopefully guide further treatment refinements of this complex
      disorder.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Bronchopulmonary Dysplasia

Intervention

MagniXene, hyperpolarized 129Xe MRI

Study Arms / Comparison Groups

 Hyperpolarized 129Xe MRI for lung diagnosis
Description:  All subjects will undergo hyperpolarized 129-Xenon MR imaging (HP MRI) and conventional proton MR imaging of lung.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Combination Product

Estimated Enrollment

30

Start Date

September 1, 2020

Completion Date

December 31, 2021

Primary Completion Date

August 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

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

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

David M Biko, MD, 267-425-7189, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04035629

Organization ID

17-014532


Responsible Party

Sponsor

Study Sponsor

Xemed LLC

Collaborators

 Children's Hospital of Philadelphia

Study Sponsor

David M Biko, MD, Principal Investigator, Children's Hospital of Philadelphia


Verification Date

June 2020