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Completed

NCT Number: NCT02723474

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

London, Ontario, N6A 5B7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

MRI at baseline and over time

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Important dates

Study start
2007
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2016
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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