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Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD

Primary Purpose

Bronchopulmonary Dysplasia, Preterm Birth

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Hyperpolarized Xenon-129

About this trial

This is an interventional basic science trial for Bronchopulmonary Dysplasia focused on measuring Proton MRI, Noble Gas MRI, Pulmonary Function

Eligibility Criteria

20 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preterm Adults

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Forced Expiratory Volume in 1 s (FEV1) measured using spirometry

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

Full Information

NCT ID

NCT02723513

First Posted

March 19, 2016

Last Updated

May 10, 2023

Sponsor

Western University, Canada

Collaborators

Université de Montréal

1. Study Identification

Unique Protocol Identification Number

NCT02723513

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2016 (Actual)

Primary Completion Date

September 2020 (Actual)

Study Completion Date

September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Western University, Canada

Collaborators

Université de Montréal

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia, Preterm Birth

Keywords

Proton MRI, Noble Gas MRI, Pulmonary Function

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Preterm Adults

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Hyperpolarized Xenon-129

Intervention Description

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 Measure Information:

Title

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

Description

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Forced Expiratory Volume in 1 s (FEV1) measured using spirometry

Time Frame

Baseline

Title

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

Description

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

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

29 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Grace Parraga, PhD

Organizational Affiliation

Western University, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5B7

Country

Canada

12. IPD Sharing Statement

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Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD

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