Brief Title
Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD
Official Title
Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult Chronic Obstructive Pulmonary Disease
Brief Summary
The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term to characterize and probe the relationship between lung structure and function using imaging.
Detailed Description
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
Primary Outcome
Number of patients with MRI-derived tissue signal intensity less than normal for age-matched individuals without BPD
Secondary Outcome
Forced Expiratory Volume in 1 s (FEV1) measured using spirometry
Condition
Bronchopulmonary Dysplasia
Intervention
Hyperpolarized Xenon-129
Study Arms / Comparison Groups
Preterm Adults
Description: 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.
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
Other
Estimated Enrollment
50
Start Date
April 1, 2016
Completion Date
April 2021
Primary Completion Date
April 2021
Eligibility Criteria
Inclusion Criteria: - 20-29 years old - Pre-term (<29 weeks gestational age) with or without a diagnosis of bronchopulmonary dysplasia (BPD) or term born controls - Subject understands the study procedures and is willing to participate in the study as indicated by the signature on the informed consent - Subject is judged to be in otherwise stable health on the basis of medical history - Subject is able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater) Exclusion Criteria: - Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material - Patient is unable to perform spirometry or plethysmography maneuvers - Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants)(at the discretion of the MRI Technologist/3T Manager) - In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia - Patient is pregnant
Gender
All
Ages
20 Years - 29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Grace Parraga, PhD, 519-931-5265, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02723513
Organization ID
ROB0041
Responsible Party
Principal Investigator
Study Sponsor
Western University, Canada
Collaborators
Université de Montréal
Study Sponsor
Grace Parraga, PhD, Principal Investigator, Western University, Canada
Verification Date
September 2019