Clinical trial NCT02723513: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Preterm Birth
Keywords: Proton MRI
Noble Gas MRI
Pulmonary Function
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Université de Montréal
First posted: 2016-03-30
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Number of patients with MRI-derived tissue signal intensity less than normal for age-matched individuals without BPD
timeFrame: Baseline
Secondary outcomes:
measure: Forced Expiratory Volume in 1 s (FEV1) measured using spirometry
timeFrame: Baseline
measure: Number of patients with abnormal Pulmonary Function measurement of surface-to volume ratio for gas exchange
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: Canada
facility: Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Grace Parraga, PhD
role: PRINCIPAL_INVESTIGATOR
References: