Imaging study using Helium-3 and Xenon-129 MRI for COPD and Bronchiectasis
Longitudinal Study of 3He and 129Xe Magnetic Resonance Imaging in Chronic Obstructive Pulmonary Disease
This study is testing new MRI imaging techniques to see how they can help doctors better understand and manage COPD and bronchiectasis in older patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Western University, Canada Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT02279329 on ClinicalTrials.gov |
What this trial studies
This study aims to develop tools for quantifying and validating longitudinal in vivo magnetic resonance imaging phenotypes in patients with chronic obstructive pulmonary disease (COPD) and bronchiectasis. Participants aged 50-85 with a clinical diagnosis of COPD or a significant smoking history will undergo various assessments, including spirometry, plethysmography, and imaging with CT and MRI. The study will stratify COPD patients into four groups based on severity and will utilize hyperpolarized helium MRI to gather detailed imaging data. The goal is to enhance understanding of these respiratory conditions and improve patient management.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 50-85 with a clinical diagnosis of COPD or bronchiectasis, or those with a smoking history of more than 10 pack-years.
Not a fit: Patients who are mentally or legally incapacitated or unable to perform the required tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and treatment strategies for patients with COPD and bronchiectasis.
How similar studies have performed: Other studies utilizing advanced imaging techniques for respiratory conditions have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects male and female aged 50-85 with either A) a clinical diagnosis of COPD or Bronchiectais or B) \>10 pack/year smoking history * 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 is ambulatory and can perform the 6MWT * Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.) * FEV1 \>25% predicted * FVC \> 25% predicted and \>0.5L 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 \<90% while lying supine. * Patient is unable to perform spirometry or plethysmography maneuvers * Patient is pregnant * 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 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.