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

May 10, 2023 updated by: Dr. Grace Parraga, Western University, Canada
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5B7
        • Recruiting
        • Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Investigators

  • Principal Investigator: Grace E Parraga, PhD, Robarts Research Institute, The University of Western Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2007

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROB0010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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