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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
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Dr. Grace Parraga, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Preterm Birth Other: Hyperpolarized Xenon-129 Not Applicable

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases
Drug Information available for: Xenon

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Forced Expiratory Volume in 1 s (FEV1) measured using spirometry [ Time Frame: Baseline ]
  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Grace Parraga, PhD 519-931-5265 gparraga@robarts.ca
Contact: Lyndsey A Reid-Jones, RPN 519-931-5777 ext 24197 lreid@robarts.ca

Locations
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Canada, Ontario
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    gparraga@robarts.ca   
Contact: Lyndsey A Reid-Jones, RPN    519-931-5777 ext 24197    lreid@robarts.ca   
Sponsors and Collaborators
Western University, Canada
Université de Montréal
Investigators
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Principal Investigator: Grace Parraga, PhD Western University, Canada

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Responsible Party: Dr. Grace Parraga, PhD, Scientist, Robarts Research Institute, Western University, Canada
ClinicalTrials.gov Identifier: NCT02723513     History of Changes
Other Study ID Numbers: ROB0041
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Keywords provided by Dr. Grace Parraga, Western University, Canada:
Proton MRI
Noble Gas MRI
Pulmonary Function

Additional relevant MeSH terms:
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Lung Diseases
Premature Birth
Bronchopulmonary Dysplasia
Respiratory Tract Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs