Exploring the Utility of Hyperpolarized 129Xe MRI in Healthy Volunteers and Patients With Lung Disease

October 30, 2023 updated by: Parameswaran Nair, McMaster University

Single-centre Study Exploring the Utility of Hyperpolarized 129Xe Magnetic Resonance Imaging in Healthy Volunteers and Patients With Lung Disease

This is a single centre exploratory study that aims to apply hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) methods and measurements in individual patients with and without lung disease to better understand lung structure and function and evaluate response to therapy delivered as a part of clinical care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate the ventilation defect percent (VDP), apparent diffusion coefficient (ADC) and/or the signal-to-noise ratio (SNR) obtained by analysis of hyperpolarized 129Xe MRI at one or more time-points (over time in the absence of therapeutic intervention or following clinically indicated therapy) in healthy volunteers and patients with lung disease including but not limited to: asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, eosinophilic granulomatosis with polyangiitis and bronchopulmonary dysplasia.

This will be a single centre exploratory study in 10 healthy volunteers with normal lung function and no history of lung disease and 50 patients with a clinical diagnosis of lung disease. There is one study visit required for participation. A subset of participants may be asked to return for up to five additional study visits per year for five years. The purpose of additional study visits is to understand how hyperpolarized 129Xe MRI measurements of lung structure and function change over time in the absence of therapeutic intervention or following clinically indicated therapy.

All subjects will visit St Joseph's Healthcare Hamilton and undergo: vital signs, pulmonary function testing, questionnaires, proton (1H) MRI, static ventilation and/or diffusion-weighted 129Xe MRI, and sputum induction. Up to four doses of hyperpolarized 129Xe will be inhaled during a single study visit.

Study Type

Interventional

Enrollment (Estimated)

60

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
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • Firestone Institute for Respiratory Health, St. Joseph's Healthcare
        • 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

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for participants with lung disease:

  • Male or female aged 18-85 years with diagnosed lung disease including but not limited to: asthma, emphysema, COPD, bronchiectasis, sarcoidosis, pulmonary fibrosis, alpha 1-anti-trypsin deficiency, eosinophilic granulomatosis with polyangiitis and bronchopulmonary dysplasia.
  • Subject understands the study procedures and is willing to participate in the study as indicated by the signature on the informed consent
  • Subject is judged to be in otherwise stable health on the basis of medical history
  • Able to read and/or understand English
  • Have a diagnosis of lung disease

Inclusion Criteria for healthy volunteers:

  • Subjects male or female aged 18-85 years
  • Subject understands the study procedures and is willing to participate in the study as indicated by the signature on the informed consent
  • Subject is judged to be in otherwise stable health on the basis of medical history
  • Able to read and/or understand English
  • No current or previous history of respiratory infection or disease

Exclusion Criteria:

  • Age < 18 years or >85 years
  • Pregnancy prior to or during study
  • In the opinion of the investigator, subject is mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
  • Patient is unable to perform spirometry or plethysmography maneuvers
  • Patient 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) (at the discretion of the MRI Technologist/3T Manager)
  • 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

Exclusion Criteria for healthy volunteers only:

  • Current or previous history of respiratory infection or disease
  • Current smoker or ex-smoker with ≥10 pack-year history

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
Experimental: Patients with and without lung disease
All enrolled patients will undergo pulmonary function testing, questionnaires, 1H MRI, static ventilation and/or diffusion-weighted hyperpolarized 129Xe MRI and sputum induction at one or more timepoints over five years.
Other: Hyperpolarized 129Xe MRI
Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas is a research approach for the non-invasive visualization and measurement of lung structure and function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilation Defect Percent (VDP)
Time Frame: 1-5 years
Whole lung and lobe specific ventilation defect percent (VDP) measured from 129Xe static ventilation magnetic resonance images.
1-5 years
Apparent Diffusion Coefficient (ADC)
Time Frame: 1-5 years
Whole lung and lobe specific apparent diffusion coefficient (ADC) measured from 129Xe diffusion-weighted magnetic resonance images.
1-5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal-to-noise ratio (SNR)
Time Frame: 1-5 years
Signal-to-noise ratio (SNR) measured from 129Xe static ventilation and diffusion-weighted magnetic resonance images.
1-5 years

Collaborators and Investigators

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

Sponsor

McMaster University

Collaborators

St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Parameswaran Nair, MD, PhD, McMaster University

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)

April 19, 2018

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 6, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIRH_Xe0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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