NCT06066723Recruiting
19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 15 (estimated)
- First submitted
- 20 Sept 2023
- Start date
- 16 Jun 2025
- Primary completion date
- Aug 2026
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Cystic fibrosis
- NCT number
- NCT06066723
What you commit to
- Study type: Observational
- Planned participants: 15
- From 16 Jun 2025 to the primary completion date, Aug 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
- 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
Other illness
- Healthy volunteers: with any history of chronic lung disease (i.e. asthma)
- Changes in medication that may affect CF lung disease or lung function in the past 28 days, including experimental therapies
Other
- Active or former smoker with less than 1 year of quitting
- Unable to tolerate the inhalation of the gas mixture
- Facial hair preventing a tight fit of the mask used in the study
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 6 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.