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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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ClinicalTrials.gov Identifier: NCT02723474
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Grace Parraga, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Lung Disease Device: MRI at baseline and over time Not Applicable

Detailed Description:

Briefly, during a one to two hour visit, subjects will provide written informed consent and then undergo:

  1. brief medical history and vital signs,
  2. full pulmonary function tests,
  3. proton MRI,
  4. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease
Actual Study Start Date : November 2007
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MRI at baseline and over time
Patients with chronic lung disease will undergo pulmonary function tests, hyperpolarized Helium and or Xenon MRI at each visit.
Device: MRI at baseline and over time
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 Measures :
  1. Lung function as measured using inhaled gas MRI ventilation defect percent (VDP) [ Time Frame: 5 years ]
    Lung function will be measured using inhaled gas MRI ventilation defect percent


Secondary Outcome Measures :
  1. Lung microstructure as measured using inhaled gas MRI Apparent Diffusion Coefficients (ADC) [ Time Frame: 5 years ]
    Lung microstructure as measured using inhaled gas MRI ADC



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

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): NCT02723474


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   
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Grace E Parraga, PhD Robarts Research Institute, The University of Western Ontario

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Grace Parraga, PhD, Scientist. Robarts Research Institute, Western University, Canada
ClinicalTrials.gov Identifier: NCT02723474     History of Changes
Other Study ID Numbers: ROB0010
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:
Magnetic Resonance Imaging
Pulmonary Function

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases