MRI imaging to understand asthma lung structure and function
Structure and Function MRI of Asthma
This study is testing how MRI scans can help us understand the lung structure and function in people with asthma to improve their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Western University, Canada Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT02351141 on ClinicalTrials.gov |
What this trial studies
This exploratory study involves 200 asthma patients who will undergo hyperpolarized noble gas MRI and various pulmonary function tests to investigate the relationship between lung structure and function. Participants will visit the Clinical Imaging Research Laboratories at Robarts Research Institute twice over three years, with additional visits for the first 60 subjects to enhance data reproducibility. The study includes comprehensive assessments such as sputum induction and dyspnea questionnaires, and patients will track their asthma control through self-assessments uploaded to a secure website.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a clinical diagnosis of asthma and stable health.
Not a fit: Patients with severe asthma or those unable to perform required pulmonary function tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of asthma and better management strategies for patients.
How similar studies have performed: While the use of hyperpolarized noble gas MRI is a novel approach, similar imaging techniques have shown promise in other respiratory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects male and female aged 18-60 with a clinical diagnosis of asthma * Smoking history ≤ 1 pack/year * Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent * 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 FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.) * FEV1 \>60% predicted 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 * Patient is unable to perform spirometry or plethysmography maneuvers * 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.) (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. * Patient is pregnant
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.