19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

Qualifiers

6-17 years old

Non-smoker and non-vaper

Cystic Fibrosis (CF) Group: must have a diagnosis of CF

No use of supplemental oxygen

Disqualifiers

Healthy volunteers: with any history of chronic lung disease (i.e. asthma)

Active or former smoker with less than 1 year of quitting

Injury to the eye involving a metallic object

Injury to the body involving a metallic object

Trial design

Treatments tested in this trial

  • 19F MRI

Treatment groups

15 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

Cystic Fibrosis Foundation

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator