Status:
RECRUITING
19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Cystic Fibrosis Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cystic Fibrosis in Children
Eligibility:
All Genders
6-17 years
Brief 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 resonan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06066723
Start Date
June 16 2025
End Date
June 1 2026
Last Update
June 18 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514