A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Observational
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 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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: t
View:

• 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

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Jennifer L Goralski, MD
jennifer_goralski@med.unc.edu
919-445-0331
Backup
Caroline Flowers, BS
caroline_flowers@med.unc.edu
984-974-2962
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2026-06
Participants
Target number of participants: 15
Treatments
Children with CF
All subjects to receive inhaled perfluoropropane during MRI procedures, including standard breath hold and free-breathing technique. Subjects will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant).
Healthy Children
All subjects to receive inhaled perfluoropropane during MRI procedures, including standard breath hold and free-breathing technique. Subjects will breathe the gas for 5 breath hold cycles (variable volumes as lung capacity/size varies per participant).
Related Therapeutic Areas
Sponsors
Collaborators: Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov