Exploring MRI's role in assessing chronic lung disease
A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease
This study is testing if MRI scans can help doctors better understand lung function in people aged 18-75 with chronic lung diseases by using a special gas to see how well their lungs are working.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Western University, Canada Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT02723474 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the utility of magnetic resonance imaging (MRI) in patients with chronic lung diseases. Participants aged 18-75 will inhale hyperpolarized helium and undergo MRI scans to evaluate various lung function metrics, including the Apparent Diffusion Coefficient (ADC) and ventilation defect volume. The study involves a comprehensive assessment of pulmonary function through established tests and imaging techniques. The goal is to enhance understanding of lung disease through advanced imaging methods.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-75 with diagnosed chronic lung diseases such as asthma, COPD, or pulmonary fibrosis.
Not a fit: Patients with unstable health conditions or those unable to perform the required pulmonary function tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diagnostic and monitoring techniques for patients with chronic lung diseases.
How similar studies have performed: While the use of MRI in lung disease assessment is emerging, this specific approach using hyperpolarized helium is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
London, Ontario
- Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Grace E Parraga, PhD — Robarts Research Institute, The University of Western Ontario
- Study coordinator: Grace Parraga, PhD
- Email: gparraga@robarts.ca
- Phone: 519-931-5265
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.