Evaluating MRI for Lung Changes in Cystic Fibrosis Patients Receiving Treatment
Assessment of CFTR-Modulator Treatment in Cystic Fibrosis Lung Disease Using Novel Structural and Functional MRI
This study is trying to see if MRI can help spot changes in the lungs of cystic fibrosis patients who are getting treatment, compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 86 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04391322 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how well MRI can detect changes in lung structure and function in patients with cystic fibrosis (CF) who are receiving CFTR-modulator therapy. Participants will include healthy controls and CF patients at different stages of treatment, with evaluations conducted over multiple visits. The study will involve various assessments, including spirometry, MRI scans, and quality of life measurements, to gather comprehensive data on lung health. The research is being conducted at The Hospital for Sick Children in Toronto.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 4 years and older with stable cystic fibrosis or healthy volunteers.
Not a fit: Patients with severe medical instability or significant lung function impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of lung changes in CF patients and improve treatment monitoring.
How similar studies have performed: While similar studies have explored MRI in lung assessments, this specific approach using CFTR-modulator therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be greater than or equal to 4 years of age * Informed consent by patient or parent/guardian consent and participant assent when appropriate. * Able to perform reproducible spirometry and achieve a breath hold duration sufficient for MRI acquisition Exclusion Criteria: * Medical instability that would preclude the ability to undergo the required investigations * FEV1 % predicted \< 40% * Severe claustrophobia * Does not meet MRI screening criteria * Cough within the past 3 days prior to study visit * Usage of oral antibiotics within 3 weeks prior to study visit
Where this trial is running
Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Giles Santyr, PhD — The Hospital for Sick Children
- Study coordinator: Giles Santyr
- Email: giles.santyr@sickkids.ca
- Phone: 4168137654
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.