Using hyperpolarized xenon-129 MRI to study lung function in healthy individuals and patients with lung disease
Single-centre Study Exploring the Utility of Hyperpolarized 129Xe Magnetic Resonance Imaging in Healthy Volunteers and Patients With Lung Disease
This study is testing a special type of MRI to see how well lungs work in both healthy people and those with lung diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT03455686 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to utilize hyperpolarized xenon-129 (129Xe) magnetic resonance imaging (MRI) to assess lung structure and function in both healthy volunteers and patients diagnosed with various lung diseases. Participants will undergo a series of tests, including pulmonary function testing and MRI scans, to evaluate metrics such as ventilation defect percent and apparent diffusion coefficient. The study will involve a single visit for all participants, with some returning for additional visits over five years to monitor changes in lung function over time. The goal is to better understand how these imaging techniques can inform treatment responses and disease progression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 with a clinical diagnosis of lung disease such as asthma, COPD, or pulmonary fibrosis.
Not a fit: Patients without a diagnosis of lung disease or those with unstable health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of lung diseases and improve monitoring and treatment strategies for patients.
How similar studies have performed: While the use of hyperpolarized xenon-129 MRI is a relatively novel approach, preliminary studies have shown promise in assessing lung function, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamilton, Ontario
- Firestone Institute for Respiratory Health, St. Joseph's Healthcare — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Parameswaran Nair, MD, PhD — McMaster University
- Study coordinator: Sarah Svenningsen, PhD
- Email: svennins@mcmaster.ca
- Phone: (905) 522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.