Actively Recruiting
19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
Led by University of North Carolina, Chapel Hill · Updated on 2026-02-17
15
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 17 years old
- Non-smoker and non-vaper
- Diagnosis of cystic fibrosis (CF) for CF group
- No use of supplemental oxygen
- Ability to perform spirometry
- Stable lung function within 10% personal best in the last 6 months
- No lung function exacerbations within the past 4 weeks
- Baseline FEV1 greater than 80% with FEV1:FVC ratio above 0.7
You will not qualify if you...
- Healthy volunteers with any history of chronic lung disease such as asthma
- Active or former smokers who quit less than 1 year ago
- Contraindications to lung and chest MRI including eye or body metallic injuries, non-MRI safe implanted drug infusion device, bone growth or fusion simulator, cochlear or ear implants, spinal or intraventricular shunts, any magnet-held implants, or claustrophobia
- Unable to tolerate inhalation of the gas mixture
- Facial hair preventing a tight mask fit
- Pregnancy
- Medication changes affecting CF lung disease or lung function in the past 28 days, including experimental therapies
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
J
Jennifer L Goralski, MD
CONTACT
C
Caroline Flowers, BS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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