19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease (NCT06066723) | Clinical Trial Compass
RecruitingNot Applicable
19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
United States15 participantsStarted 2025-06-16
Plain-language summary
This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children.
Children and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel "free-breathing" technique that will eliminate the need for breath holds during MRI acquisition.
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 6-17 years old
* Non-smoker and non-vaper
* Cystic Fibrosis (CF) Group: must have a diagnosis of CF
* No use of supplemental oxygen
* They must be able to perform spirometry and have stable lung function (within 10% personal best in the last 6 months) and no exacerbations within the past 4 weeks
* Baseline forced expiratory volume in 1 second (FEV1) \>80% with ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung (FEV1:FVC) ratio \>0.7
Exclusion Criteria:
* Healthy volunteers: with any history of chronic lung disease (i.e. asthma)
* Active or former smoker with less than 1 year of quitting
* Unable to undergo an MRI of the lungs and chest because of contraindications, including:
* Injury to the eye involving a metallic object
* Injury to the body involving a metallic object
* Presence of an implanted drug infusion device that is not MRI safe
* Bone growth of fusion simulator
* Presence of cochlear, otologic, or ear implant
* Shunt (spinal or intraventricular)
* Any implant held in place by magnet
* Claustrophobia
* Unable to tolerate the inhalation of the gas mixture
* Facial hair preventing a tight fit of the mask used in the study
* Pregnancy
* Changes in medication that may affect CF lung disease or lung function in the past 28 days, including experimental therapies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participation rate
Timeframe: through study completion, recruitment for 2 years
2
Completion rate
Timeframe: through study completion, recruitment for 2 years