Using Xenon MRI to evaluate lung disease
A Study Evaluating Hyperpolarized 129 Xenon Magnetic Resonance Imaging in Subjects With Chronic Lung Disease
This study is testing a special type of MRI using Xenon gas to see if it can help people with lung diseases understand how well their lungs are working.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Western University, Canada Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT02723500 on ClinicalTrials.gov |
What this trial studies
This study involves subjects aged 18-85 with various lung diseases who will undergo hyperpolarized Xenon 129 MRI and pulmonary function testing. The goal is to develop tools for evaluating lung function through measurements such as the Apparent Diffusion Coefficient (ADC) and ventilation defect percent (VDP). Participants will complete a series of tests including medical history, vital signs, and multiple imaging techniques during a one to two hour visit. The study aims to enhance the understanding of pulmonary gas exchange and lung function in patients with chronic lung conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 with diagnosed lung diseases such as asthma, COPD, or pulmonary fibrosis.
Not a fit: Patients with unstable health conditions or those unable to perform the required breathhold may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools for assessing lung function in patients with chronic lung diseases.
How similar studies have performed: Other studies using hyperpolarized gas MRI have shown promise in evaluating lung function, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects male and female aged 18-85 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, and lymphangioleiomyomatosis (LAM) * 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 at 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 \>0.5 liter Exclusion Criteria: * Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material. * Subject has a daytime room air oxygen saturation ≤ 92% ± 2% while supine. * Patient is unable to perform spirometry or plethysmography maneuvers * Subject unable to tolerate MRI due to patient size and/or known history of claustrophobia. * Patient is pregnant or lactating * 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 MRI incompatible 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 E 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.