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A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease

Primary Purpose

Lung Disease

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MRI at baseline and over time
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lung Disease focused on measuring Magnetic Resonance Imaging, Pulmonary Function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects male and female aged 18-75 with diagnosed lung disease including but not limited to: asthma, emphysema, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, lymphangioleiomyomatosis (LAM) and Bronchiolitis obliterans organizing pneumonia (BOOP)
  • Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
  • Subject must be able to perform a breathhold for 16s.
  • Subject is judged to be in otherwise stable health on the basis of medical history
  • Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume in one second (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
  • FEV1 >25% predicted
  • Forced Vital Capacity (FVC) > 25% predicted and >0.5Liters

Exclusion Criteria:

  • Subject with a contraindication to Magnetic Resonance Imaging (i.e. ferrous implants, cardiac pacemakers). This will be determined through a screening form.
  • Subject has a daytime room air oxygen saturation <90% while lying supine.
  • Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia.
  • Subject previously injured by a metallic object that was not removed.
  • 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.
  • 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.)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRI at baseline and over time

Arm Description

Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Helium and or Xenon MRI at each visit.

Outcomes

Primary Outcome Measures

Lung function as measured using inhaled gas MRI ventilation defect percent (VDP)
Lung function will be measured using inhaled gas MRI ventilation defect percent

Secondary Outcome Measures

Lung microstructure as measured using inhaled gas MRI Apparent Diffusion Coefficients (ADC)
Lung microstructure as measured using inhaled gas MRI ADC

Full Information

First Posted
December 7, 2015
Last Updated
May 10, 2023
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02723474
Brief Title
A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease
Official Title
A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2007 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Male and female subjects age 18-85 with lung disease will inhale 5ml/kg (patient body weight) hyperpolarized helium and will be scanned using MRI at 3 Tesla, to evaluate the Apparent Diffusion Coefficient (ADC), ventilation defect volume and percent ventilation.
Detailed Description
Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo: brief medical history and vital signs, full pulmonary function tests, proton MRI, spin-density and/or diffusion weighted Helium-3 MRI. Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Lung Clearance Index (LCI) and Airwave Oscillometry (AO) will be performed according to ATS guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, MN USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, MA USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
Magnetic Resonance Imaging, 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
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI at baseline and over time
Arm Type
Other
Arm Description
Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Helium and or Xenon MRI at each visit.
Intervention Type
Device
Intervention Name(s)
MRI at baseline and over time
Intervention Description
Hyperpolarized noble gas MRI has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI, Helium-3 and Xenon-129 gas is used as a contrast agent to directly visualize ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.
Primary Outcome Measure Information:
Title
Lung function as measured using inhaled gas MRI ventilation defect percent (VDP)
Description
Lung function will be measured using inhaled gas MRI ventilation defect percent
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Lung microstructure as measured using inhaled gas MRI Apparent Diffusion Coefficients (ADC)
Description
Lung microstructure as measured using inhaled gas MRI ADC
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects male and female aged 18-75 with diagnosed lung disease including but not limited to: asthma, emphysema, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, lymphangioleiomyomatosis (LAM) and Bronchiolitis obliterans organizing pneumonia (BOOP) Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent Subject must be able to perform a breathhold for 16s. Subject is judged to be in otherwise stable health on the basis of medical history Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have Forced Expiratory Volume in one second (FEV1) values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.) FEV1 >25% predicted Forced Vital Capacity (FVC) > 25% predicted and >0.5Liters Exclusion Criteria: Subject with a contraindication to Magnetic Resonance Imaging (i.e. ferrous implants, cardiac pacemakers). This will be determined through a screening form. Subject has a daytime room air oxygen saturation <90% while lying supine. Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia. Subject previously injured by a metallic object that was not removed. 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. 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Parraga, PhD
Phone
519-931-5265
Email
gparraga@robarts.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Angela A Wilson, RRT
Phone
519-931-5777
Ext
24197
Email
awilson@robarts.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace E Parraga, PhD
Organizational Affiliation
Robarts Research Institute, The University of Western Ontario
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace E Parraga, PhD
Phone
519-931-5265
Email
gparraga@robarts.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
31638491
Citation
Westcott A, Capaldi DPI, McCormack DG, Ward AD, Fenster A, Parraga G. Chronic Obstructive Pulmonary Disease: Thoracic CT Texture Analysis and Machine Learning to Predict Pulmonary Ventilation. Radiology. 2019 Dec;293(3):676-684. doi: 10.1148/radiol.2019190450. Epub 2019 Oct 22.
Results Reference
derived
PubMed Identifier
28258250
Citation
Kirby M, Eddy RL, Pike D, Svenningsen S, Coxson HO, Sin DD, McCormack DG, Parraga G; Canadian Respiratory Research Network. MRI ventilation abnormalities predict quality-of-life and lung function changes in mild-to-moderate COPD: longitudinal TINCan study. Thorax. 2017 May;72(5):475-477. doi: 10.1136/thoraxjnl-2016-209770. Epub 2017 Mar 3.
Results Reference
derived

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A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease

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