Actively Recruiting
A Cross-sectional Pilot Study of 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
N/A
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
Researchers are studying the use of a new imaging technique called 19F MRI that uses an inert gas, perfluoropropane mixed with oxygen, to visualize lung ventilation. This method has not been tested in children before. The study involves children and adolescents aged 6 to 17 years with cystic fibrosis (CF) who have normal lung function, as well as a group of healthy children of the same age range. The goal is to assess if this imaging can be done successfully in the pediatric population and compare results between the two groups. Participants will inhale perfluoropropane gas during MRI scans using two techniques: standard breath holds and a novel free-breathing method that avoids breath holding. Each participant will breathe the gas for five breath hold cycles, with volumes adjusted for their lung size. Both children with CF and healthy children will undergo these procedures to compare lung ventilation images and lung function measures. During the single study visit, participants will undergo 19F MRI scans and lung function tests including spirometry and multiple breath nitrogen washout (MBW). Researchers will assess how well children tolerate the procedures using acceptability scores from both parents and children. The main focus is on the feasibility of performing these scans in children, with secondary measures assessing lung ventilation details. The study lasts for recruitment over two years and includes participation and completion rates as key outcomes.
CONDITIONS
Brief 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 6 to 17 years
- Non-smoker and non-vaper
- Diagnosis of cystic fibrosis for CF group
- No use of supplemental oxygen
- Able to perform spirometry with stable lung function (within 10% of personal best in last 6 months)
- No lung exacerbations within past 4 weeks
- Baseline FEV1 greater than 80% with FEV1:FVC ratio greater than 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 MRI including metallic injuries or implants, cochlear or ear implants, shunts, magnetic implants, or claustrophobia
- Unable to tolerate inhaling the gas mixture
- Facial hair preventing a tight mask fit
- Pregnancy
- Medication changes affecting CF lung disease or lung function in past 28 days, including experimental therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo 19F MRI involving inhalation of a biologically inert contrast gas during breath-hold and free-breathing techniques to assess lung ventilation.
1 visit (in-person)
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
C
Caroline Flowers, BS
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here