Are you healthy and looking to help advance medical science?

You may be eligible to participate in a bronchopulmonary dysplasia clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a bronchopulmonary dysplasia clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Bronchopulmonary Dysplasia Clinical Trial in London Ontario

NCT02723513 | Interventional

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a bronchopulmonary dysplasia clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a bronchopulmonary dysplasia clinical study, and could be compensated for your time.

Completed

Male & Female

20 - 29

Years old

This study has recruited 3 Participants

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.

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Details for the study

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 <br /> imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years <br /> born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term <br /> 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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Number of patients with MRI-derived tissue signal intensity less than normal for age-matched individuals without BPD

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.

Baseline

Secondary

Number of patients with abnormal Pulmonary Function measurement of surface-to volume ratio for gas exchange

diffusing capacity of carbon monoxide (DLCO) as a percent of predicted value for normal subjects of the same age and size

Baseline

Study 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