Recruiting

Hyperpolarized 129Xe MRI

Sponsor:

McMaster University

Code:

NCT03455686

Conditions

Asthma

Chronic Obstructive Pulmonary Disease

Bronchiectasis

Emphysema

Pulmonary Fibrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Hyperpolarized 129Xe MRI

Study Details

Brief summary:

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.

Conditions

Asthma

Chronic Obstructive Pulmonary Disease

Bronchiectasis

Emphysema

Pulmonary Fibrosis

Study ID

NCT03455686

Start date

Apr 19, 2018

Status verified date

May, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Ventilation Defect Percent (VDP) [ Time Frame: 1-5 years ]
  • Apparent Diffusion Coefficient (ADC) [ Time Frame: 1-5 years ]

Central Contacts and Locations

Central contacts

Sarah Svenningsen, PhD

(905) 522-1155svennins@mcmaster.ca

Melanie Kjarsgaard, RRT

(905) 522-1155mkjarsga@stjosham.on.ca

Locations

Firestone Institute for Respiratory Health, St. Joseph's Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Sarah Svenningsen, PhD

905-522-1155svennins@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

May 21, 2024

Last verified

May, 2024

Keywords

  • magnetic resonance imaging
  • hyperpolarized xenon-129
  • lung function
  • lung structure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-05-21.