Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04035629
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-16
First Post:
2019-05-31
Brief Title:
129Xe MRI in Pediatric Population With BPD
Sponsor:
Xemed LLC
Organization:
Xemed LLC
Study Overview
Official Title:
A Prospective Study of Hyperpolarized 129 Xe MRI in in a Pediatric Population With Bronchopulmonary Dysplasia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 radiographs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None