Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD
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|ClinicalTrials.gov Identifier: NCT02723513|
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bronchopulmonary Dysplasia Preterm Birth||Other: Hyperpolarized Xenon-129||Not Applicable|
This is a pilot, cross-sectional exploratory study to evaluate the relationship between imaging and other biomarkers in fifty patients born pre-term (with or without bronchopulmonary dysplasia [BPD]) and age-matched healthy controls. The term-born adults will serve as the controls.
All subjects will visit the Clinical Imaging Research Laboratories at Robarts Research Institute or the University of Montreal University Health Centre Sainte-Justine in a single visit and undergo: vital signs, pulmonary function testing (more specifically: spirometry, body plethysmography, airwave oscillation, and lung clearance index), questionnaires, proton and 129Xe MRI. Preterm patients will also have a low-dose chest computed tomography (CT), and have blood and urine samples taken for biomarkers of inflammation and oxidative stress.
MRI of the lungs will be performed using non-contrast enhanced methods (ultra-short echo time [UTE] MRI) and using an inhaled contrast agent: Hyperpolarized Xenon-129. Participants will inhale the hyperpolarized gas and perform a breathhold for up to 16 seconds. Four different types of images will be acquired in the coronal plain during each visit: 1) 1H thoracic cavity, 2) 129Xe static ventilation, 3) 129Xe diffusion weighted imaging, and, 4) multi-volume UTE MRI. Respiration and oxygen saturation will be monitored throughout the imaging session.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult Chronic Obstructive Pulmonary Disease|
|Actual Study Start Date :||April 1, 2016|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: Preterm Adults
All enrolled preterm adults will undergo non-contrast enhanced MRI (using ultra-short echo time methods), hyperpolarized noble gas MRI (using hyperpolarized xenon-129), x-ray computed tomography (CT), pulmonary function tests, and questionnaires in a single visit.
Other: Hyperpolarized Xenon-129
Hyperpolarized Xenon-129. Noble gas magnetic resonance imaging (MRI) has recently emerged as another research approach for the non-invasive measurement of lung structure and function, including conduction of gas through airways and into airspaces.
Noble gas MRI provides a complimentary and alternative method for evaluating lung disease and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function.
- Number of patients with MRI-derived tissue signal intensity less than normal for age-matched individuals without BPD [ Time Frame: Baseline ]This will be measured using non-contrast enhanced MRI methods (ultra-short echo time MRI) and hyperpolarized noble gas MRI methods. Mean whole lung signal intensity measurements will be quantified after the UTE MRI acquisition. Ventilation defect percent and apparent diffusion coefficients will be determined after noble gas MR acquisition.
- Forced Expiratory Volume in 1 s (FEV1) measured using spirometry [ Time Frame: Baseline ]
- Number of patients with abnormal Pulmonary Function measurement of surface-to volume ratio for gas exchange [ Time Frame: Baseline ]diffusing capacity of carbon monoxide (DLCO) as a percent of predicted value for normal subjects of the same age and size
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723513
|Contact: Grace Parraga, PhDfirstname.lastname@example.org|
|Contact: Lyndsey A Reid-Jones, RPN||519-931-5777 ext email@example.com|
|Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A 5B7|
|Contact: Grace E Parraga, PhD 519-931-5265 firstname.lastname@example.org|
|Contact: Lyndsey A Reid-Jones, RPN 519-931-5777 ext 24197 email@example.com|
|Principal Investigator:||Grace Parraga, PhD||Western University, Canada|