NCT04391322Active, not recruiting
Assessment of CFTR-Modulator Treatment in Cystic Fibrosis Lung Disease Using Novel Structural and Functional MRI
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
This is a prospective, longitudinal observational study conducted at The Hospital for Sick Children (SickKids). The purpose of this study is to evaluate the ability of MRI to detect changes in lung structure and function in CF patients receiving CFTR-modulator therapy. Participants who meet eligibility criteria and consent to the study will undergo study procedures which include spirometry and body plethysmography (optional), multiple breath washout testing, MRI and measurement of quality of life. The study will consist of three to six study visits for Group 1, 2 and 3: baseline, one month (±1 week) and 6 month (±2 week) and if they re-consent then 3 additional visits of 1 year (±6 months). (2 years (±6 months) and 3 years (±6 months) follow-up. Some participants in Group 2 may transition to Group 3. This study includes three populations of interest: Group 1: 25 healthy volunteers, Group 2: 25 patients with stable CF lung disease , Group 3: 20 patients with CF lung disease anticipated to receive treatment with CFTR-modulator therapy and Group 4: 18 patients with CF who are between 4-8 years old and are starting triple combination modulator therapy using the rapid lung and abdominal imaging methods.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 86 (estimated)
- First submitted
- 12 May 2020
- Start date
- 20 Oct 2020
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- The Hospital for Sick Children
- Diseases
- Cystic fibrosis
- NCT number
- NCT04391322
What you commit to
- Study type: Observational
- Planned participants: 86
- From 20 Oct 2020 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cough within the past 3 days prior to study visit
- Usage of oral antibiotics within 3 weeks prior to study visit
Other
- Medical instability that would preclude the ability to undergo the required investigations
- FEV1 % predicted \< 40%
- Severe claustrophobia
- Does not meet MRI screening criteria
Who the study is looking for
- 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
Age in the registry: 4 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.