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

NCT02723474 | Completed

• 1 other identifier: ROB0010
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease

Keywords

Magnetic Resonance Imaging; Pulmonary Function

Outcome Measures

Primary Outcomes (1)

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

  Lung function will be measured using inhaled gas MRI ventilation defect percent

  5 years

Secondary Outcomes (1)

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

  5 years

Study Arms (1)

MRI at baseline and over time

OTHER

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

Interventions

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.

MRI at baseline and over time

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

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

London, Ontario, N6A 5B7, Canada

Location

Related Publications (2)

• 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.

  PMID: 31638491 DERIVED

• 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.

  PMID: 28258250 DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Grace E Parraga, PhD

  Robarts Research Institute, The University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Scientist. Robarts Research Institute

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: March 30, 2016
• Study Start: November 1, 2007
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2024-06

Locations

CA (1)